Hepatitis C, ChronicPhase 4NCT01033448
A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response
A Phase 4 study testing COPEGUS and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 20 sites in Israel.
Trial summary
This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. 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?
- COPEGUS and peginterferon alfa-2a [Pegasys]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 20 sitesIsrael
- Study dates
- Dec 2009to 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
- Chronic hepatitis C, genotype 1, 2, 3
- Compensated liver disease
- Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders
Who cannot join
- Decompensated liver disease
- Signs or symptoms of hepatocellular carcinoma
- Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Israel20 sites
Haemek Hospital; Gastroenterology
Afula, 18101
Clalit City Ashdod MC; Liver Clinic
Ashdod, 77444
Batyamon; Liver Unit
Bat Yam
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
Kaplan Medical Center; Gastroenterology Unit
Rehovot, 76100
Clalit Pinsker Rishon; Liver Clinic
Rishon LeZiyyon, 75299
Rebecca Sieff Medical Center; Liver Unit
Safed, 13110
Maccabi Health Services MC
Tel Aviv, 67891
Poria Hospital; Gastroenterology
Tiberias
Assaf Harofeh; Gastroenterology
Tsrifin, 6093000
About this study
Official title: An Open-Label, Multi-Center Study Evaluating the Effect on Viral Activity and the Safety and Tolerability of Extended Treatment of Pegasys® (Peginterferon Alfa 2a ) in Combination With Copegus® (Ribavirin) in Genotype 1, 2 and 3 Chronic Hepatitis C Patients Defined as Slow Responders/Non-RVR
This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
- Conditions
- Hepatitis C, Chronic
- Being tested
- COPEGUS, peginterferon alfa-2a [Pegasys]
- 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.
COPEGUSDrug
COPEGUS 800 mg or 1000-1200 mg po for 24 weeks
peginterferon alfa-2a [Pegasys]Drug
PEGASYS 180 micrograms sc once weekly for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Drug: COPEGUS; Drug: peginterferon alfa-2a [Pegasys] |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of Treatment Response Rate at Week 72 in Genotype 1
End of treatment response rate at Week 72 was reported for genotype 1.
Measured: Week 72
End of Treatment Response in Genotype 2 and 3
End of treatment response rate at Week 48 was reported for genotype 2 and 3.
Measured: Week 48
Sustained Viral Response (SVR) Rates in CHC Genotype 1
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.
Measured: Week 96
SVR Rates in Genotype 2 and 3.
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.
Measured: Week 72
Secondary outcomes (1)
Percentage of Participants With Adverse Event (AE)
An AE is defined as 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.
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2013
- Study completionJun 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 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
- NCT01033448
- Sponsor's protocol ID
- ML21778
- Status last verified
- May 2017
- First submitted
- 15 Dec 2009
- Last updated
- 3 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Study Evaluating the Effect on Viral Activity and the Safety and Tolerability of Extended Treatment of Pegasys® (Peginterferon Alfa 2a ) in Combination With Copegus® (Ribavirin) in Genotype 1, 2 and 3 Chronic Hepatitis C Patients Defined as Slow Responders/Non-RVR
- ClinicalTrials.gov ID
- NCT01033448
- Acronym / sponsor ID
- ML21778
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Posted 3 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: COPEGUS, Drug: peginterferon alfa-2a [Pegasys] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients >/= 18 years of age
- Chronic hepatitis C, genotype 1, 2, 3
- Compensated liver disease
- Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders
Key exclusion criteria (3 listed)
- Decompensated liver disease
- Signs or symptoms of hepatocellular carcinoma
- Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
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 |
|---|---|---|
| COPEGUSCOPEGUS 800 mg or 1000-1200 mg po for 24 weeks | Drug | Single arm |
| peginterferon alfa-2a [Pegasys]PEGASYS 180 micrograms sc once weekly for 24 weeks | Drug | Single arm |
Primary outcome
End of Treatment Response Rate at Week 72 in Genotype 1
Time frame: Week 72
End of treatment response rate at Week 72 was reported for genotype 1.
End of Treatment Response in Genotype 2 and 3
Time frame: Week 48
End of treatment response rate at Week 48 was reported for genotype 2 and 3.
Sustained Viral Response (SVR) Rates in CHC Genotype 1
Time frame: Week 96
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.
SVR Rates in Genotype 2 and 3.
Time frame: Week 72
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.
1 secondary outcome
Percentage of Participants With Adverse Event (AE)
Time frame: Week 96
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- 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
20 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 COPEGUS and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 20 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 4 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 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 3 Oct 2017). 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?
End of Treatment Response Rate at Week 72 in Genotype 1 (time frame: Week 72). The study lists 4 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 3 Oct 2017.