Hepatitis C, ChronicNCT01604291

An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 21 sites in Israel.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic
How many people: 991 participants
Where: 21 sitesIsrael
Study dates: 28 May 2012to 10 Feb 2016
Phase: Observational
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Chronic hepatitis C patients initiating Pegasys-based treatment

Who may be able to join

Adult patients, >/= 18 years of age
Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)
Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)
No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information
Quantitative serum HCV RNA by PCR test before initiation of treatment

Who cannot join

Hepatitis A/B co-infection
Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Pregnant or breast-feeding women

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

Israel21 sites

Haemek Hospital; Gastroenterology
Afula, 18101
Barzilai MC; Gastroenterology
Ashkelon, 78278
Soroka Medical Center; Gastroenterology
Beersheba, 84105
Hillel Yaffe Hospital; Gastroenterology
Hadera, 38100
Rambam Medical Center; Gastroenterology - Liver Unit
Haifa, 31096
Bnei-Zion Medical Center; Gastroenterology
Haifa, 33394
Carmel Hospital; Liver Unit
Haifa, 34362
Wolfson Hospital; Gastroenterology Unit
Holon, 58100
Shaare Zedek Hospital Liver Unit; Liver Unit
Jerusalem, 91031
Hadassah Hospital; Liver Unit
Jerusalem, 91120
Meir Medical Center; Liver Unit
Kfar Saba, 44281
Western Galilee Hospital - Nahariya
Nahariya, 22100
Holy Family Medical Center; Liver Unit
Nazareth
Beilinson-Rabin Liver Unit; Liver Unit
Petah Tikva
Hasharon Mc; Gastroenterology
Petah Tikva
Sheba Medical Center; Tel Hashomer
Ramat Gan, 5262100
Kaplan Medical Center; Gastroenterology Unit
Rehovot, 76100
Rebecca Sieff Medical Center; Liver Unit
Safed, 13110
Tel-Aviv Sourasky Medical Center; Liver Unit
Tel Aviv, 6423906
Poria Hospital; Gastroenterology
Tiberias
Assaf Harofeh; Gastroenterology
Tsrifin, 6093000

Other trials in Israel

About this study

Official title: Multi-Center, Non-Interventional Study, on the Efficacy of Dual and Triple Therapies Based on Pegylated Interferon Alfa-2a for the Treatment of Chronic Hepatitis C Patients

This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.

Conditions: Hepatitis C, Chronic
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.

Study groups in NCT01604291
Study group	Role	What they receive
Cohort		Not described

What is being measured

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

Percentage of Participants With Sustained Viral Response (SVR) at Week 24
The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion.
Measured: Week 24

Secondary outcomes (15)

Comparison of SVR at Week 24
SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype.
Measured: Week 24
Number of Participants With SVR at Week 24 According to the Demographic Characteristics
The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants.
Measured: Week 24
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
RVR was defined as HCV-RNA <50 IU/mL by Week 4
Measured: Week 4
Percentage of Participants With Extended RVR
Extended RVR was defined as HCV-RNA <50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 \& 24 for participants treated with boceprevir.
The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'.
Measured: Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group
Percentage of Participants With Complete Early Virologic Response (cEVR)
Complete early virologic response (cEVR) was defined as HCV-RNA <50 IU/mL by Week 12
Measured: Week 12
Percentage of Participants With End of Treatment Response (EoT)
End-of-Treatment (EoT) response was defined as HCV-RNA <50 IU/mL by the end of treatment.
Measured: Week 24
Percentage of Participants With Virologic Relapse
Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA <50 IU/mL at EoT.
Measured: Week 72
Treatment Duration
The average amount of time a treatment was prescribed to participants.
Measured: Week 48
Time to First Dose Modification of Peginterferon Alfa-2a
Measured: Week 48
Time to First Dose Modification of Ribavirin
Measured: Week 48
Time to First Dose Modification of Telaprevir/Boceprevir
Measured: Week 48
Percentage of Participants With Adverse Events (AEs)
Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants.
Measured: Week 48
Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia
Measured: Week 48
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia
Measured: Week 48
Percentage of Participants Who Had SVR at Week 24 With Dose Modifications
Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study.
Measured: Week 24

Timeline

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

28 May 201210 Feb 2016

First posted23 May 2012 (estimated)
Study start28 May 2012
Primary completion10 Feb 2016
Study completion10 Feb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 991 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01604291
Sponsor's protocol ID: ML28268
Status last verified: Nov 2018
First submitted: 21 May 2012
Last updated: 14 Mar 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center, Non-Interventional Study, on the Efficacy of Dual and Triple Therapies Based on Pegylated Interferon Alfa-2a for the Treatment of Chronic Hepatitis C Patients
ClinicalTrials.gov ID: NCT01604291
Acronym / sponsor ID: ML28268
Conditions: Hepatitis C, Chronic
Study type: Observational
Recruitment status: Completed
Enrolment: 991 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Collaborators: Clalit Health Services
Study start: 28 May 2012 (actual)
Primary completion: 10 Feb 2016 (actual)
Study completion: 10 Feb 2016 (actual)
First posted: 23 May 2012 (estimated)
Results: Posted 14 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cohort	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Chronic hepatitis C patients initiating Pegasys-based treatment

Key inclusion criteria (5 listed)

Adult patients, >/= 18 years of age
Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)
Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)
No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information
Quantitative serum HCV RNA by PCR test before initiation of treatment

Key exclusion criteria (3 listed)

Hepatitis A/B co-infection
Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Pregnant or breast-feeding women

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Participants With Sustained Viral Response (SVR) at Week 24
Time frame: Week 24
The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion.

15 secondary outcomes

Comparison of SVR at Week 24
Time frame: Week 24
Number of Participants With SVR at Week 24 According to the Demographic Characteristics
Time frame: Week 24
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
Time frame: Week 4
Percentage of Participants With Extended RVR
Time frame: Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group
Percentage of Participants With Complete Early Virologic Response (cEVR)
Time frame: Week 12
Percentage of Participants With End of Treatment Response (EoT)
Time frame: Week 24
Percentage of Participants With Virologic Relapse
Time frame: Week 72
Treatment Duration
Time frame: Week 48
Time to First Dose Modification of Peginterferon Alfa-2a
Time frame: Week 48
Time to First Dose Modification of Ribavirin
Time frame: Week 48
Time to First Dose Modification of Telaprevir/Boceprevir
Time frame: Week 48
Percentage of Participants With Adverse Events (AEs)
Time frame: Week 48
Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia
Time frame: Week 48
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia
Time frame: Week 48
Percentage of Participants Who Had SVR at Week 24 With Dose Modifications
Time frame: Week 24

Results and safety

Results posted to the registry on 14 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Peginterferon Alfa-2a + Ribavirin	311	311
Peginterferon Alfa-2a + Ribavirin + Telaprevir	443	443
Peginterferon Alfa-2a + Ribavirin + Boceprevir	193	193
No Information on Treatment Allocation	44	44

Primary outcome: Percentage of Participants With Sustained Viral Response (SVR) at Week 24

Time frame: Week 24. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Peginterferon Alfa-2a + Ribavirin n = 303	Peginterferon Alfa-2a + Ribavirin + Telaprevir n = 442	Peginterferon Alfa-2a + Ribavirin + Boceprevir n = 190
Value	87.2 (81.1 to 91.9)	94.8 (91.6 to 97.1)	85.2 (77.4 to 91.1)

Population analysed: Modified All Treated (mTRT) Population: includes all participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; the participants' treatment documentation was sufficient for assignment to treatment groups.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 48. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Peginterferon Alfa-2a + Ribavirin	24 of 311 (7.7%)	208 of 311 (66.9%)	Not reported
Peginterferon Alfa-2a + Ribavirin +Telaprevir	78 of 445 (17.5%)	338 of 445 (76%)	Not reported
Peginterferon Alfa-2a + Ribavirin + Boceprevir	26 of 192 (13.5%)	161 of 192 (83.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C, Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 21 sites in Israel.

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 3 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 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Israel. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2019). 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 Sustained Viral Response (SVR) at Week 24 (time frame: Week 24). 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 NCT01604291.

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 14 Mar 2019.