Hepatitis C, ChronicPhase 4NCT01429792
A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
A Phase 4 study testing peginterferon alfa-2a [Pegasys] and ribavirin [Copegus] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 26 sites in Israel.
Trial summary
This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- peginterferon alfa-2a [Pegasys] and ribavirin [Copegus]
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,013 participants
- Where
- 26 sitesIsrael
- Study dates
- 25 Sep 2008to 10 Jun 2013
- Phase
- Phase 4
- 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
Who may be able to join
- Adult patients, >/= 18 years of age
- Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test
- Documented pre-treatment HCV RNA quantitative result
- Compensated liver disease (Child-Pugh Grade A)
- Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)
Who cannot join
- Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
- Co-infection with active hepatitis A and/or hepatitis B
- History or evidence of a medical condition associated with liver disease other than HCV
- Signs and symptoms of hepatocellular carcinoma
- History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
- Therapy with antineoplastic treatment </= 6 months prior to study day
Show all 9Show fewer
- Diabetes mellitus in subjects receiving an insulin therapy
- Evidence of severe retinopathy
- Pregnant or breast-feeding women, and male partners of women who are pregnant
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Israel26 sites
Haemek Hospital; Gastroenterology
Afula, 18101
Clalit City Ashdod MC; Liver Clinic
Ashdod, 77444
Barzilai MC; Gastroenterology
Ashkelon, 78278
Batyamon; Liver Unit
Bat Yam
Soroka Medical Center; Liver Unit
Beersheba, 8410101
Soroka Medical Center; Gastroenterology
Beersheba, 84105
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
Hadassah Hospital; Liver Unit
Jerusalem, 91120
Clalit Strauss MC
Jerusalem, 95146
Meir Medical Center; Gastroenterology
Kfar Saba, 44281
Naharyia / Western Galilee MC; Gastro Unit
Nahariya, 22100
Holy Family Medical Center; Gastroenterology
Nazareth
Rabin Medical Center; Gastroenterology - Liver Unit
Petah Tikva, 49100
Hasharon Mc; Gastroenterology
Petah Tikva
Chaim Sheba Medical Center; Gastroenterology
Ramat Gan, 52621
Kaplan Medical Center; Gastroenterology Unit
Rehovot, 76100
Clalit Pinsker Rishon; Liver Clinic
Rishon LeZiyyon, 75299
Rebecca Sieff; Gastroenterology
Safed, 13110
Sourasky / Ichilov Hospital; Gastroenterology - Liver Unit
Tel Aviv, 6423906
Clalit Zamenhoff
Tel Aviv, 64353
Maccabi Health Services MC
Tel Aviv, 67891
Poria Hospital; Gastroenterology
Tiberias
Assaf Harofeh; Gastroenterology
Tsrifin, 6093000
About this study
Official title: A Multi-Center Study Evaluating the Rate of Genotype 1, 2, 3 & 4 Chronic Hepatitis C Patients With Slow Response / Non-rapid Viral Response to Anti-Viral Treatment of Pegasys (Peginterferon Alfa 2a) in Combination With Copegus (Ribavirin)
This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 \& 3) or 48 weeks (genotype 1 \& 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.
- Conditions
- Hepatitis C, Chronic
- Being tested
- peginterferon alfa-2a [Pegasys], ribavirin [Copegus]
- 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.
peginterferon alfa-2a [Pegasys]Drug
standard treatment, subcutaneously weekly
ribavirin [Copegus]Drug
standard treatment, orally daily
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment
The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
Measured: Week 12
Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment
Measured: Week 12
Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24
The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment
Measured: Week 24
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.
Measured: Week 4
Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment
The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.
Measured: Week 4
Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24
The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.
Measured: Week 24
Secondary outcomes (3)
Percentage of Participants With pEVR to Study Treatment at Week 12
The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
Measured: Week 12
Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment.
Measured: Week 12
Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24
The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study start25 Sep 2008
- Primary completion10 Jun 2013
- Study completion10 Jun 2013
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429792
- Sponsor's protocol ID
- ML21779
- Status last verified
- Dec 2017
- First submitted
- 5 Sep 2011
- Last updated
- 23 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study Evaluating the Rate of Genotype 1, 2, 3 & 4 Chronic Hepatitis C Patients With Slow Response / Non-rapid Viral Response to Anti-Viral Treatment of Pegasys (Peginterferon Alfa 2a) in Combination With Copegus (Ribavirin)
- ClinicalTrials.gov ID
- NCT01429792
- Acronym / sponsor ID
- ML21779
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,013 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2008 (actual)
- Primary completion
- 10 Jun 2013 (actual)
- Study completion
- 10 Jun 2013 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Posted 23 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 \& 3) or 48 weeks (genotype 1 \& 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin [Copegus] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients, >/= 18 years of age
- Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test
- Documented pre-treatment HCV RNA quantitative result
- Compensated liver disease (Child-Pugh Grade A)
- Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)
Key exclusion criteria (9 listed)
- Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
- Co-infection with active hepatitis A and/or hepatitis B
- History or evidence of a medical condition associated with liver disease other than HCV
- Signs and symptoms of hepatocellular carcinoma
- History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peginterferon alfa-2a [Pegasys]standard treatment, subcutaneously weekly | Drug | Single Arm |
| ribavirin [Copegus]standard treatment, orally daily | Drug | Single Arm |
Primary outcome
Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment
Time frame: Week 12
The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment
Time frame: Week 12
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment
Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24
Time frame: Week 24
The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
Time frame: Week 4
The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.
Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment
Time frame: Week 4
The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.
Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24
Time frame: Week 24
The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.
3 secondary outcomes
Percentage of Participants With pEVR to Study Treatment at Week 12
Time frame: Week 12
Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment
Time frame: Week 12
Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing peginterferon alfa-2a [Pegasys] and ribavirin [Copegus] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 26 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 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 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 23 Oct 2018). 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 Partial Early Virological Response (pEVR) to Study Treatment (time frame: Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2018.