Hepatitis C, ChronicPhase 4NCT00087646
REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy
A Phase 4 study testing Ribavirin and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 104 sites in 14 countries.
Trial summary
This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with… 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?
- Ribavirin and peginterferon alfa-2a [Pegasys]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 948 participants
- Where
- 104 sitesin 14 countries
- Study dates
- Sep 2003to May 2008
- 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;
- CHC infection;
- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
- use of 2 forms of contraception during study and 6 months after the study in both men and women;
- Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks.
Who cannot join
- women who are pregnant or breastfeeding;
- male partners of women who are pregnant;
- conditions associated with decompensated liver disease;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection.
Trial locations and contacts
104 sites in 14 countries.
104 sites in 14 countries
United States36 sites
Study site
Albuquerque, New Mexico, 87131
Study site
Atlanta, Georgia, 30308
Study site
Atlanta, Georgia, 30309
Study site
Austin, Texas, 78758
Study site
Baltimore, Maryland, 21224
Study site
Boston, Massachusetts, 02114
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Boston, Massachusetts, 02215
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Bradenton, Florida, 34243
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Burlington, Vermont, 05401
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Chicago, Illinois, 60611
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Chicago, Illinois, 60612
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Cranston, Rhode Island, 02920
Study site
Des Moines, Iowa, 50312
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Farmington, Connecticut, 06030
Study site
Florham Park, New Jersey
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Hollywood, Florida, 33021
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Houston, Texas, 77054
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Jacksonville, Florida, 32256
Study site
Kansas City, Missouri, 64131
Study site
Lancaster, Pennsylvania, 17604-3200
Study site
Los Angeles, California, 90033
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Memphis, Tennessee, 38120
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Minneapolis, Minnesota, 55404-4565
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Mobile, Alabama, 36693
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Nashville, Tennessee, 37211
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Pasadena, California, 91105
Study site
Philadelphia, Pennsylvania, 19104
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Richmond, Virginia, 23249
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Rochester, Minnesota, 55905
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Salt Lake City, Utah, 84121
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San Diego, California, 92123
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Savannah, Georgia, 31404
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Scottsdale, Arizona, 85259
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St Louis, Missouri, 63110
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Ukiah, California, 95482
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Williamsville, New York, 14221
Germany19 sites
Study site
Berlin, 13353
Study site
Bochum, 44791
Study site
Bonn, 53127
Study site
Cologne, 50937
Study site
Düsseldorf, 40225
Study site
Düsseldorf, 40237
Study site
Erlangen, 91054
Study site
Frankfurt am Main, 60596
Study site
Freiburg im Breisgau, 79106
Study site
Hamburg, 20246
Study site
Hanover, 30625
Study site
Heidelberg, 69120
Study site
Homburg/saar, 66424
Study site
Kassel, 34125
Study site
Kiel, 24105
Study site
Mainz, 55101
Study site
München, 81377
Study site
Oberhausen, 46145
Study site
Würzburg, 97080
Spain10 sites
Study site
Alicante, 03010
Study site
Barcelona, 08036
Study site
Granada, 18003
Study site
Madrid, 28007
Study site
Madrid, 28035
Study site
Madrid, 28046
Study site
Málaga, 29010
Study site
Santander, 39008
Study site
Seville, 41014
Study site
Valencia, 46014
France9 sites
Study site
Clichy, 92118
Study site
Créteil, 94010
Study site
Lille, 59037
Study site
Lyon, 69288
Study site
Marseille, 13385
Study site
Montpellier, 34295
Study site
Paris, 75651
Study site
Pessac, 33604
Study site
Toulouse, 31059
Italy7 sites
Study site
Bari, 70100
Study site
Bologna, 40138
Study site
Milan, 20122
Study site
Padova, 35128
Study site
Palermo, 90127
Study site
Roma, 00133
Study site
Torino, 10126
Greece4 sites
Study site
Alexandroupoli, 68100
Study site
Athens, 10552
Study site
Athens, 11527
Study site
Thessaloniki, 546 42
Turkey (Türkiye)4 sites
Study site
Ankara, 06100
Study site
Istanbul, 34390
Study site
Istanbul, 81190
Study site
Izmir, 35100
Belgium3 sites
Study site
Brussels, 1200
Study site
Ghent, 9000
Study site
Leuven, 3000
Canada3 sites
Study site
Toronto, Ontario, M5G 1X5
Study site
Toronto, Ontario, M6H 3M1
Study site
Vancouver, British Columbia, V5Z 1H2
Portugal3 sites
Study site
Coimbra, 3000-075
Study site
Lisbon, 1150-314
Study site
Lisbon, 1649-035
Sweden3 sites
Study site
Gothenburg, 41685
Study site
Huddinge, 14186
Study site
Lund, 22185
About this study
Official title: A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy
This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Ribavirin, 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.
RibavirinDrug
1000/1200mg po daily for 72 weeks
RibavirinDrug
1000/1200mg po daily for 48 weeks
peginterferon alfa-2a [Pegasys]Drug
360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks
peginterferon alfa-2a [Pegasys]Drug
360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks.
peginterferon alfa-2a [Pegasys]Drug
180 micrograms sc weekly for 72 weeks
peginterferon alfa-2a [Pegasys]Drug
180 micrograms sc weekly for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Ribavirin; Drug: peginterferon alfa-2a [Pegasys] |
| 2 | Experimental | Not described Receives: Drug: Ribavirin; Drug: peginterferon alfa-2a [Pegasys] |
| 3 | Experimental | Not described Receives: Drug: Ribavirin; Drug: peginterferon alfa-2a [Pegasys] |
| 4 | Active comparator | Not described Receives: Drug: Ribavirin; Drug: peginterferon alfa-2a [Pegasys] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Sustained Virological Response Rate
Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.
Measured: Up to 72 weeks (Group A) and 48 weeks (Group D)
Secondary outcomes (7)
Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)
SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.
Measured: At Week 48 and Week 72
Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)
SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.
Measured: At Week 48 and Week 72
Percentage of Participants With Undetectable HCV-RNA
The percentage of participants with a undetectable HCV RNA 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 IU/mL measured >= 20 weeks after treatment end, ie, >=140 days after treatment end) are reported.
End-of-treatment (EOT) virological response is defined as last HCV RNA measurement that is not detectable (<50 IU/mL) at study day of last dose of study medication (+/- 28 days).
Measured: At Week 12, 24, 48 and EOT
Percentage of Participants With >=2log Drop in HCV-RNA
Reduction in HCV-RNA titers of at least 2 log10 after 12/24 weeks of study treatment (i.e. 99% reduction of viral load) was analyzed. Percentage of participants with at least a 2 log10 drop of HCV-RNA at study week 12 and 24 (lower limit of quantitation 600 IU/mL) as compared to baseline or non-detectable HCV-RNA (lower limit of detection 50 IU/mL) were reported.
Measured: At Week 12 and 24
Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)
The mean change from baseline in HCV RNA level (reduction in viral load) at Week 12 and 24 were determined. HCV RNA result were not detectable (<50 IU/ML) and not quantifiable (<600 IU/ML). Baseline value were assessed on Day 1 before the administration of the first dose of study drug.
Measured: At Week 12 and 24
Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response
Maintenance of end-of-treatment virological response was assessed based on all participants treated and according to the actual treatment period (backward imputation method). The percentage of participants who maintained their end-of-treatment virological response was determined. Maintenance of actual end-of-treatment virological response was calculated by dividing the number of participants with a virological response both at the end of the actual untreated follow-up period and at the end of the actual treatment period by the number of participants with a virological response at the actual end of treatment.
Measured: Week 96 (Group A and C) and Week 72 (Group B and D)
Percentage of Participants With Relapse After End of Treatment
The percentage of participants who relapsed (loss of response) after having achieved a virological response at the end of treatment was determined.
Measured: Week 96 (Group A and C) and Week 72 (Group B and D)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2004 (estimated)
- Study startSep 2003
- Primary completionMay 2008
- Study completionMay 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 948 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
- NCT00087646
- Sponsor's protocol ID
- MV17150
- Status last verified
- Dec 2015
- First submitted
- 12 Jul 2004
- Last updated
- 14 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Marcellin P, Craxi A, Brandao-Mello CE, Di Bisceglie AM, Andreone P, Freilich B, Rajender Reddy K, Olveira Martin A, Teuber G, Messinger D, Hooper G, Wat C, Tatsch F, Jensen DM. Predicting early and sustained virological responses in prior nonresponders to pegylated interferon alpha-2b plus ribavirin retreated with peginterferon alpha-2a plus ribavirin and the benefit-risk ratio of retreatment. J Clin Gastroenterol. 2013 Oct;47(9):786-93. doi: 10.1097/MCG.0b013e31827b9b45.
PubMed 23442834
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy
- ClinicalTrials.gov ID
- NCT00087646
- Acronym / sponsor ID
- MV17150
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 948 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 14 Jul 2004 (estimated)
- Results
- Posted 14 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ribavirin, Drug: peginterferon alfa-2a [Pegasys] |
| 2 | Experimental | Drug: Ribavirin, Drug: peginterferon alfa-2a [Pegasys] |
| 3 | Experimental | Drug: Ribavirin, Drug: peginterferon alfa-2a [Pegasys] |
| 4 | Active comparator | Drug: Ribavirin, 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 (5 listed)
- adult patients >=18 years of age;
- CHC infection;
- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
- use of 2 forms of contraception during study and 6 months after the study in both men and women;
- Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks.
Key exclusion criteria (5 listed)
- women who are pregnant or breastfeeding;
- male partners of women who are pregnant;
- conditions associated with decompensated liver disease;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection.
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 |
|---|---|---|
| Ribavirin1000/1200mg po daily for 72 weeks | Drug | 1, 3 |
| Ribavirin1000/1200mg po daily for 48 weeks | Drug | 2, 4 |
| peginterferon alfa-2a [Pegasys]360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks | Drug | 1 |
| peginterferon alfa-2a [Pegasys]360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks. | Drug | 2 |
| peginterferon alfa-2a [Pegasys]180 micrograms sc weekly for 72 weeks | Drug | 3 |
| peginterferon alfa-2a [Pegasys]180 micrograms sc weekly for 48 weeks | Drug | 4 |
Primary outcome
Number of Participants With Sustained Virological Response Rate
Time frame: Up to 72 weeks (Group A) and 48 weeks (Group D)
Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.
7 secondary outcomes
Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)
Time frame: At Week 48 and Week 72
Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)
Time frame: At Week 48 and Week 72
Percentage of Participants With Undetectable HCV-RNA
Time frame: At Week 12, 24, 48 and EOT
Percentage of Participants With >=2log Drop in HCV-RNA
Time frame: At Week 12 and 24
Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)
Time frame: At Week 12 and 24
Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response
Time frame: Week 96 (Group A and C) and Week 72 (Group B and D)
Percentage of Participants With Relapse After End of Treatment
Time frame: Week 96 (Group A and C) and Week 72 (Group B and D)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23442834Marcellin P, Craxi A, Brandao-Mello CE, Di Bisceglie AM, Andreone P, Freilich B, Rajender Reddy K, Olveira Martin A, Teuber G, Messinger D, Hooper G, Wat C, Tatsch F, Jensen DM. Predicting early and sustained virological responses in prior nonresponders to pegylated interferon alpha-2b plus ribavirin retreated with peginterferon alpha-2a plus ribavirin and the benefit-risk ratio of retreatment. J Clin Gastroenterol. 2013 Oct;47(9):786-93. doi: 10.1097/MCG.0b013e31827b9b45.
- This is a full publication titled Re-treatment of Patients With Chronic Hepatitis C Who Do Not Respond to Peginterferon- alfa2b, A Randomized TrialLink provided by the sponsor.
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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
104 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ribavirin and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 104 sites in 14 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 5 inclusion and 5 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 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, Germany, Spain, France, Italy and 9 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 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 14 Jan 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?
Number of Participants With Sustained Virological Response Rate (time frame: Up to 72 weeks (Group A) and 48 weeks (Group D)). 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 NCT00087646, 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 14 Jan 2016.