Hepatitis C, ChronicPhase 3NCT01853254
A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials
A Phase 3 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 67 sites in 11 countries.
Trial summary
This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. 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 and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 67 sitesin 11 countries
- Study dates
- Sep 2003to Sep 2011
- Phase
- Phase 3
- 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.
- Compensated liver disease (Child-Pugh Class A).
- Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.
- Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
- Have not received any other anti-hepatitis C virus treatment after the completion of the donor protocol.
- For females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug.
- Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.
Who cannot join
- Pregnant or breastfeeding women.
- Male partners of women who are pregnant.
- Patients with hemoglobinopathies.
- Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
- Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
- Liver disease other than chronic hepatitis C, including hepatic carcinoma.
Trial locations and contacts
67 sites in 11 countries.
67 sites in 11 countries
United States49 sites
Study site
Atlanta, Georgia, 30308
Study site
Atlanta, Georgia, 30309
Study site
Aurora, Colorado, 80045
Study site
Baltimore, Maryland, 21205
Study site
Bellevue, Washington, 98004
Study site
Binghamton, New York, 13903
Study site
Birmingham, Alabama, 35295-0005
Study site
Boise, Idaho, 83702
Study site
Charlottesville, Virginia, 22906-0013
Study site
Cleveland, Ohio, 44106
Study site
Dallas, Texas, 75203
Study site
Durham, North Carolina, 27710
Study site
Framingham, Massachusetts, 01702
Study site
Gainesville, Florida, 32610-0214
Study site
Gainesville, Florida, 32610
Study site
Germantown, Tennessee, 38138
Study site
Honolulu, Hawaii, 96817
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46202
Study site
Iowa City, Iowa, 52242
Study site
Jacksonville, Florida, 32209
Study site
Kansas City, Kansas, 66160
Study site
La Jolla, California, 92037-1030
Study site
Lancaster, Pennsylvania, 17604-3200
Study site
Long Beach, California, 90822
Study site
Manhasset, New York, 11030
Study site
Marietta, Georgia, 30060
Study site
Miami, Florida, 33136-1051
Study site
New York, New York, 10016
Study site
New York, New York, 10021
Study site
Newark, New Jersey, 07102
Study site
Orlando, Florida, 32803
Study site
Orlando, Florida, 32809
Study site
Philadelphia, Pennsylvania, 19104
Study site
Plymouth, Minnesota, 55446
Study site
Portland, Oregon, 97201
Study site
Poughkeepsie, New York, 12601
Study site
Providence, Rhode Island, 02905
Study site
San Antonio, Texas, 78215
Study site
San Diego, California, 92123
Study site
San Diego, California, 92154
Study site
San Francisco, California, 94115
Study site
Sarasota, Florida, 34243
Study site
Seattle, Washington, 98133
Study site
Statesville, North Carolina, 28677
Study site
Tacoma, Washington, 98403
Study site
Vineland, New Jersey, 08360
Study site
Wellington, Florida, 33414
Study site
Worcester, Massachusetts, 01655
Brazil4 sites
Study site
Ribeirão Preto, 14049-900
Study site
Salvador, 40150-130
Study site
São Paulo, 01246-000
Study site
São Paulo, 1323020
Puerto Rico4 sites
Study site
Ponce, 00716
Study site
San Juan, 00921-3200
Study site
San Juan, 00936-5067
Study site
Santurce, 00909
About this study
Official title: An Open-label, Multicenter Protocol Providing Pegylated Interferon Alfa-2a (Pegasys®) as Monotherapy or in Combination With Ribavirin (Copegus®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols
This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Peginterferon alfa-2a, Ribavirin
- 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-2aDrug
Also called Pegasys
Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly.
RibavirinDrug
Also called Copegus
For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing < 75 kg or 1200 mg orally daily for participants weighing ≥ 75 kg, in 2 split doses, for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon alfa-2a monotherapy or combined with ribavirin | Experimental | The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy. Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least 1 Adverse Event
Measured: From Baseline to the end of the study (up to 72 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startSep 2003
- Primary completionSep 2011
- Study completionSep 2011
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853254
- Sponsor's protocol ID
- NV17590
- Status last verified
- Jun 2013
- First submitted
- 10 May 2013
- Last updated
- 4 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Protocol Providing Pegylated Interferon Alfa-2a (Pegasys®) as Monotherapy or in Combination With Ribavirin (Copegus®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols
- ClinicalTrials.gov ID
- NCT01853254
- Acronym / sponsor ID
- NV17590
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 May 2013 (estimated)
- Results
- Posted 4 Sep 2013
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, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peginterferon alfa-2a monotherapy or combined with ribavirin | Experimental | Drug: Peginterferon alfa-2a, Drug: RibavirinThe treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients, ≥ 18 years of age.
- Chronic hepatitis C.
- Compensated liver disease (Child-Pugh Class A).
- Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.
- Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women.
- Male partners of women who are pregnant.
- Patients with hemoglobinopathies.
- Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
- Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
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-2aAlso: PegasysBoth combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly. | Drug | Peginterferon alfa-2a monotherapy or combined with ribavirin |
| RibavirinAlso: CopegusFor genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing < 75 kg or 1200 mg orally daily for participants weighing ≥ 75 kg, in 2 split doses, for 48 weeks. | Drug | Peginterferon alfa-2a monotherapy or combined with ribavirin |
Primary outcome
Percentage of Participants With at Least 1 Adverse Event
Time frame: From Baseline to the end of the study (up to 72 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
- 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 chair
Hoffmann-La Roche
67 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 67 sites in 11 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 8 inclusion and 6 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 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Brazil, Puerto Rico, Australia, Italy and 6 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 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?
Yes. Results are posted in the registry (first posted 4 Sep 2013). 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 at Least 1 Adverse Event (time frame: From Baseline to the end of the study (up to 72 weeks)). 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 4 Sep 2013.