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AzTrials

Hepatitis B, ChronicPhase 3NCT01519960

A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

A Phase 3 study testing peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 39 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B. Read more about this study

Who is it for?
Ages 3 to 17 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
peginterferon alfa-2a [Pegasys]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
39 sitesin 12 countries
Study dates
11 Jul 2012to 18 Oct 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male or female patients, 3 years to <18 years of age at baseline
  • Positive HBsAg for more than 6 months
  • Positive HBeAg and detectable HBV DNA at screening
  • A liver biopsy obtained within the past 2 years prior to baseline (and more than 6 months after the end of previous therapy for hepatitis B) to confirm the presence of advanced fibrosis or exclude cirrhosis
  • Compensated liver disease (Child-Pugh Class A)
  • Elevated serum alanine transferase (ALT)
  • Normal thyroid gland function at screening

Who cannot join

  • Subjects with cirrhosis
  • Subjects must not have received investigational drugs or licensed treatments with anti-HBV activity within 6 months of baseline. Subjects who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded
  • Known hypersensitivity to peginterferon
  • Positive test results at screening for hepatitis A, hepatitis C, hepatitis D or HIV infection
  • History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis B
  • History or evidence of bleeding from esophageal varices
Show all 9Show fewer
  • Decompensated liver disease (e.g. ascites, Child-Pugh Class B or C)
  • History of immunologically mediated disease
  • Pregnant or lactating females

Trial locations and contacts

39 sites in 12 countries.

39 sites in 12 countries

China10 sites

  • Beijing 302 Hospital; No. 2 Infectious Disease Section

    Beijing, 100039

  • Beijing You An Hospital; Digestive Dept

    Beijing, 100069

  • the First Hospital of Jilin University

    Changchun, 130021

  • Southwest Hospital , Third Military Medical University

    Chongqing, 400038

  • The Eighth People's Hospital of Guangzhou

    Guangzhou, 510060

  • The Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, 510630

  • The First Affilliated Hospital of Kunming Medical College

    Kunming, 650032

  • Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine

    Urumqi (乌鲁木齐), 830000

  • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

    Wuhan, 430030

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

Other trials in China

United States6 sites

  • Johns Hopkins Hospital - Pediatric Gastroenterology

    Baltimore, Maryland, 21287-5554

  • Children's Hospital Boston-Harvard Medical School; Division of Gastoenterology

    Boston, Massachusetts, 02115

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Univ of California SF, Benioff Children's Hospital; Pediatrics, Gastro, Hepatology & Nutrition

    San Francisco, California, 94143

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • St. Louis University - Cardinal Glennon Children's Medical Center

    St Louis, Missouri, 63104

Other trials in United States

Russia4 sites

  • SFI Sceintific Research institute of nutrition of RAMS

    Moscow, 115446

  • SI Sceintific children health center RAMS

    Moscow, 119991

  • FSI Scientific research Institute of children's infections

    Saint Petersburg, 197022

  • MC Gepatolog

    Samara, 443100

Other trials in Russia

Israel3 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Western Galilee Hospital - Nahariya

    Nahariya, 22100

Other trials in Israel

Poland3 sites

  • Wojewodzki Szpital Obserwacyjno-Zakazny; Oddział Pediatrii, Chorób Infekcyjnych i Hepatologii

    Bydgoszcz, 85-030

  • Krakowski Szpital Specjalistyczny im Jana Pawła II; Oddział Chorób Infekcyjnych Dzieci

    Krakow, 31-202

  • Wojewodzki Specjalistyczny Szpital im. Dr W.Bieganskiego; Oddział Obserwacyjno-Zakażny dla Dzieci

    Lodz, 91-347

Other trials in Poland

United Kingdom3 sites

  • Birmingham Children'S Hopsital; Liver Unit

    Birmingham, B4 6NH

  • Kings College Hospital NHS Foundation Trust

    London, SE5 9RS

  • Imperial College Healthcare Trust

    London, W2 1PG

Other trials in United Kingdom

Australia2 sites

  • Royal Children's Hospital; Department of Gastroenterology

    Melbourne, Victoria, 3053

  • Womens and Childrens Hospital; Department of Gastroenterology

    North Adelaide, South Australia, 5006

Other trials in Australia

Belgium2 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Gent

    Ghent, 9000

Other trials in Belgium

Bulgaria2 sites

  • Specialized Hospital for Active Treatment of Pediatrics Diseases; Clinic of Gastroenterology

    Sofia, 1612

  • University Hospital "St. Marine"; Dept. of Pediatrics

    Varna, 9000

Other trials in Bulgaria

Ukraine2 sites

  • Kyiv Children's Clinical Infectious Diseases Hospital

    Kyiv, 01119

  • SI Institute of the pediatrics, obstetrics and gynecology

    Kyiv, 04050

Other trials in Ukraine

Germany1 site

  • HELIOS Klinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin, Universität Witten-Herdecke

    Wuppertal, 42283

Other trials in Germany

Italy1 site

  • Uni Degli Studi Di Bologna - Policlinica S. Orsola; Inst. Di Malattie Infettive

    Bologna, Emilia-Romagna, 40138

Other trials in Italy

About this study

Official title: A Phase IIIb Parallel Group, Open Label Study of Pegylated Interferon Alfa-2a Monotherapy (PEG-IFN, Ro 25-8310) Compared to Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment with Pegasys. Children in the untreated control Group B who have not experienced seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of Pegasys treatment. This offer will be available for 1 year following 48 weeks from randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period.

Being tested
peginterferon alfa-2a [Pegasys]
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • peginterferon alfa-2a [Pegasys]Drug

    Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48

  • peginterferon alfa-2a [Pegasys]Drug

    Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, after Week 48 for Group B patients who have not experienced HBeAg seroconversion

Study groups in NCT01519960
Study groupRoleWhat they receive
A PegasysExperimentalNot described
Receives: Drug: peginterferon alfa-2a [Pegasys]
B Untreated ControlNo interventionNot described
C Fibrosis non-randomizedExperimentalNot described
Receives: Drug: peginterferon alfa-2a [Pegasys]
SwitchExperimentalNot described
Receives: Drug: peginterferon alfa-2a [Pegasys]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B

    HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.

    Measured: FU Week 24 (up to 72 weeks overall)

Secondary outcomes (72)

  1. Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B

    The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  2. Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B

    HBsAg seroconversion was defined as loss of HBsAg and the presence of hepatitis B surface antibody (anti-HBs). The percentage of participants with HBsAg seroconversion at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  3. Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B

    Normal ALT was defined as ALT less than or equal to (≤) ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  4. Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B

    HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  5. Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B

    HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  6. Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  7. Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  8. Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: Week 48

  9. Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B

    The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: Week 48

  10. Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B

    HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: Week 48

  11. Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B

    The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: Week 48

  12. Percentage of Participants With Normal ALT at EOT/POP in Groups A and B

    Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: Week 48

  13. Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B

    HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: Week 48

  14. Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B

    HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: Week 48

  15. Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B

    HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: Week 48

  16. Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: Week 48

  17. Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: Week 48

  18. Quantitative Serum ALT Level in Groups A and B

    Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

  19. Quantitative HBV DNA Level in Groups A and B

    Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

  20. Change From Baseline in Quantitative HBV DNA Level in Groups A and B

    The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

  21. Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C

    The percentage of participants with loss of HBeAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population: All participants who received at least one dose of study drug (if assigned) and had at least one post-baseline safety assessment.

    Measured: FU Week 24 (up to 72 weeks overall)

  22. Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C

    HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  23. Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C

    The percentage of participants with loss of HBsAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population

    Measured: FU Week 24 (up to 72 weeks overall)

  24. Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C

    Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  25. Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C

    HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  26. Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C

    HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  27. Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C

    HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  28. Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  29. Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  30. Percentage of Participants With HBeAg Seroconversion at EOT in Group C

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: Week 48

  31. Percentage of Participants With Loss of HBeAg at EOT in Group C

    The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: Week 48

  32. Percentage of Participants With HBsAg Seroconversion at EOT in Group C

    HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: Week 48

  33. Percentage of Participants With Loss of HBsAg at EOT in Group C

    The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: Week 48

  34. Percentage of Participants With Normal ALT at EOT in Group C

    Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: Week 48

  35. Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C

    HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: Week 48

  36. Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C

    HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: Week 48

  37. Percentage of Participants With HBV DNA Undetectable at EOT in Group C

    HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: Week 48

  38. Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: Week 48

  39. Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: Week 48

  40. Quantitative Serum ALT Level in Group C

    Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

  41. Quantitative HBV DNA Level in Group C

    Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

  42. Change From Baseline in Quantitative HBV DNA Level in Group C

    The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

  43. Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category

    AUC was estimated using population pharmacokinetic (PK) modeling. The AUC at steady-state was averaged among participants who received PEG-IFN and reported by BSA category. Categories of BSA-based dosing used in the analysis were as follows: 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. The estimated AUC was expressed in hours by nanograms per milliliter (h*ng/mL). PK Substudy Population: All participants who consented to participate in the PK substudy. "Number of subjects analyzed" reflects the total combined number of participants who provided evaluable data across all BSA categories. The number of participants who provided evaluable data within each BSA category (n) is shown in the table.

    Measured: Pre-dose (0 hours) at Baseline and Weeks 4, 8, 12, 24; post-dose (24-48, 72-96, 168 hours) during Weeks 1, 24 (up to 24 weeks overall)

  44. Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B

    The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)

  45. Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B

    The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

  46. Quantitative HBeAg Level in Groups A and B

    Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL). ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

  47. Quantitative HBsAg Level in Groups A and B

    Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

  48. Quantitative HBeAg Level in Group C

    Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

  49. Quantitative HBsAg Level in Group C

    Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.

    Measured: Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

  50. Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C

    Liver elastography was performed to assess elasticity and extent of hepatic fibrosis. The change in LSM from Baseline to each visit was averaged among all participants in expressed in kilopascals (kPa). Positive changes in LSM values corresponded to an increase in stiffness and hepatic fibrosis. Liver Substudy Population: All participants who consented to participate in the liver elasticity substudy. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Week 48; FU Week 24 (up to 72 weeks overall)

  51. Percentage of Participants With >15% Drop in Height Percentile for Age in Group C

    The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population.

    Measured: Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)

  52. Change From Baseline in Height for Age Z-Score in Groups A and B

    The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)

  53. Change From Baseline in Weight for Age Z-Score in Groups A and B

    The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

  54. Change From Baseline in Height for Age Z-Score in Group C

    The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population.

    Measured: Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)

  55. Change From Baseline in Weight for Age Z-Score in Group C

    The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

  56. Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  57. Change From Baseline in Quantitative Serum ALT Level in Groups A and B

    The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

  58. Change From Baseline in Quantitative HBeAg Level in Groups A and B

    The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. ITT Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

  59. Change From Baseline in Quantitative HBsAg Level in Groups A and B

    The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

  60. Change From Baseline in Quantitative Serum ALT Level in Group C

    The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

  61. Change From Baseline in Quantitative HBeAg Level in Group C

    The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

    Measured: Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

  62. Change From Baseline in Quantitative HBsAg Level in Group C

    The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.

    Measured: Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

  63. Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: Baseline, FU Years: 1, 2, 3, 4, 5

  64. Percentage of Participants With Loss of HBeAg at 24 Weeks After the End of Switch Treatment Period: Switch Group

    The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  65. Percentage of Participants With HBsAg Seroconversion at 24 Weeks After the End of Switch Treatment Period: Switch Group

    HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.

    Measured: FU Week 24 (up to 72 weeks overall)

  66. Percentage of Participants With Loss of HBsAg at 24 Weeks After the End of Switch Treatment Period: Switch Group

    HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.

    Measured: FU Week 24 (up to 72 weeks overall)

  67. Percentage of Participants With Normal ALT at 24 Weeks After the End of Switch Treatment Period: Switch Group

    Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  68. Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After the End of Switch Treatment Period: Switch Group

    HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  69. Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group

    HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  70. Percentage of Participants With HBV DNA Undetectable at 24 Weeks After the End of Switch Treatment Period: Switch Group

    HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  71. Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

  72. Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group

    HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

    Measured: FU Week 24 (up to 72 weeks overall)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2012 (estimated)
  2. Study start11 Jul 2012
  3. Primary completion9 Jul 2015
  4. Study completion18 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01519960
Sponsor's protocol ID
YV25718
Other IDs
2011-002732-70
Status last verified
Oct 2022
First submitted
6 Dec 2011
Last updated
18 Nov 2022

Publications

  • Wirth S, Zhang H, Hardikar W, Schwarz KB, Sokal E, Yang W, Fan H, Morozov V, Mao Q, Deng H, Huang Y, Yang L, Frey N, Nasmyth-Miller C, Pavlovic V, Wat C. Efficacy and Safety of Peginterferon Alfa-2a (40KD) in Children With Chronic Hepatitis B: The PEG-B-ACTIVE Study. Hepatology. 2018 Nov;68(5):1681-1694. doi: 10.1002/hep.30050. Epub 2018 Oct 8.

    PubMed 29689122

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 39 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in China, United States, Russia, Israel, Poland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B (time frame: FU Week 24 (up to 72 weeks overall)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01519960, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.

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