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Chronic Hepatitis CPhase 3NCT01581398

Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients

A Phase 3 study testing Ypeginterferon alfa-2b and Pegasys in people with Chronic Hepatitis C, run by Xiamen Amoytop Biotech Co., Ltd. at 42 sites in China.

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

The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis C
What is being tested?
Ypeginterferon alfa-2b and Pegasys
Could I receive a placebo?
No, everyone receives an active treatment
How many people
770 participants
Where
42 sitesChina
Study dates
Apr 2012to Jun 2014
Phase
Phase 3
Are there results?
None posted in the registry

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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18~65 years
  • Hepatitis virus C chronic infection evidences: HCV RNA or anti-HCV positive>6 months,or other evidences supporting diagnosis of chronic hepatitis C infection
  • HCV RNA≥2000IU/mL, anti-HCV positive at screening
  • Pregnancy tests for female patients must be negative. All patients must take effective contraception measures during the study period
  • Signed informed consent

Who cannot join

  • Pregnant or lactating women
  • Mental or psychology disorder
  • ANC<1500/mm3, or PLT<90,000/mm3, or Hb<ULN(Upper limit of Normal)
  • Received interferon treatment within the previous 6 months or shown no-response to previous interferon treatment
  • Co-infection with HIV, HAV, HBV, HEV
  • Evidence of hepatic decompensation (e.g: Child Plug≥B, prothrombin time prolonged more than 3 seconds, TBil>2ULN, Alb<35g/L)
Show all 11Show fewer
  • Hepatocarcinoma or suffering from any other malignant tumor
  • Not well controlled endocrine diseases(e.g:thyroid disfunction, mellitus mellitus)
  • Significant function damage in any major organs (e.g: heart, lung, kidney)
  • Involved in other investigation within the previous 3 months
  • Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g: poor compliance)

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

China42 sites

  • 302 Military Hospital

    Beijing

  • Beijing Youan Hospital, Capital Medical University

    Beijing

  • Beijing Youyi Hospital, capital Medical University

    Beijing

  • Peking University First Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • First Affiliated Hospital of Jilin University

    Changchun

  • Xiangya Hospital, Central-south University

    Changsha

  • Xiangya Second Hospital, Central-south University

    Changsha

  • West China Hospital, Sichuan University

    Chengdu

  • Second Affiliated Hospital Chongqing Medical University

    Chongqing

  • Southwest Hospital

    Chongqing

  • Fuzhou Infectious Disease Hospital

    Fuzhou

  • Guangzhou Eighth People's Hospital

    Guangzhou

  • Nanfang Hospital

    Guangzhou

  • Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou

  • First Affiliated Hospital of Guangxi Medical University

    Guilin

  • Affiliated Hospital of Guiyang Medical College

    Guiyang

  • First Affiliated Hospital, Zhejiang University

    Hangzhou

  • Second Affiliated Hospital of Harbin Medical University

    Harbin

  • First Affiliated Hospital of Anhui Medical University

    Hefei

  • Jinan Infectious Disease Hospital

    Jinan

  • First Affiliated Hospital of Lanzhou University

    Lanzhou

  • First Affiliated Hospital of Nanchang University

    Nanchang

  • 81 Military Hospital

    Nanjing

  • Jiangsu Province Hospital

    Nanjing

  • Second Hospital of Nanjing

    Nanjing

  • 85 Militay Hospital

    Shanghai

  • Huashan Hospital

    Shanghai

  • Renji Hospital

    Shanghai

  • Ruijing Hospital

    Shanghai

  • Shanghai Public Health Clinical Center

    Shanghai

  • Third Affiliated Hospital, Hebei Medical University

    Shijiazhuang

  • First Affiliated Hospital, Shanxi University

    Taiyuan

  • Tianjin Third Central Hospital

    Tianjin

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

  • Tangdu Hospital, Fourth Military Medical University

    Xi'an

  • Xijing Hospital

    Xi'an

  • The First Affiliated Hospital of Xiamen University

    Xiamen

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou

  • Hennan Provincial People's Hospital

    Zhengzhou

Other trials in China

About this study

Official title: A Phase 3, Randomized, Multi-center, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Combination With Ribavirin in Chinese Chronic Hepatitis C Patients

The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks after the end of therapy.

Being tested
Ypeginterferon alfa-2b, Pegasys
Keywords
Peginterferon, Pegasys, Sustained virus response, HCV
Medical subject headings
Hepatitis C, Chronic

What participants receive

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

  • Ypeginterferon alfa-2bDrug

    sc, qw, 24 weeks.

  • PegasysDrug

    sc, qw, 24 weeks.

  • Ypeginterferon alfa-2bDrug

    sc, qw, 48 weeks.

  • PegasysDrug

    sc, qw, 48 weeks.

Study groups in NCT01581398
Study groupRoleWhat they receive
A1(Genotype2/3)ExperimentalYpeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day
Receives: Drug: Ypeginterferon alfa-2b
A2(Genotype 2/3)Active comparatorPegasys 180μg/week, in combination with Ribavirin 800mg/day
Receives: Drug: Pegasys
B1(Non-genotype 2/3)ExperimentalYpeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight
Receives: Drug: Ypeginterferon alfa-2b
B2(Non-genotype 2/3)Active comparatorPegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.
Receives: Drug: Pegasys

What is being measured

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

  1. Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy)

    Measured: 24 weeks after the end of therapy

Secondary outcomes (1)

  1. Proportion of patients with HCV RNA undetectable (defined as HCV RNA <15IU/ml)

    Measured: at weeks 4, 12, 24 for genotype 2/3, and weeks 4, 12, 24 and 48 for non-genotype 2/3

Timeline

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

  1. First posted20 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionApr 2014
  4. Study completionJun 2014

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
770 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01581398
Sponsor's protocol ID
TB1203IFN
Status last verified
Apr 2012
First submitted
16 Feb 2012
Last updated
7 Oct 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ypeginterferon alfa-2b and Pegasys in people with Chronic Hepatitis C, run by Xiamen Amoytop Biotech Co., Ltd. at 42 sites in China.

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 5 inclusion and 11 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 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy) (time frame: 24 weeks after the end of therapy). 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 NCT01581398.

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 7 Oct 2014.

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