Hepatitis C, ChronicPhase 4NCT00940420
A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C
A Phase 4 study testing Copegus (ribavirin) and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 20 sites in Israel.
Trial summary
This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. 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 (ribavirin) and peginterferon alfa-2a [Pegasys]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,695 participants
- Where
- 20 sitesIsrael
- Study dates
- Oct 2002to Nov 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 infection
- compensated liver disease
- negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment
Who cannot join
- history or other evidence of a medical condition associated with chronic liver disease other than HCV
- hepatitis A, hepatitis B or HIV infection
- hepatocellular carcinoma
- severe concomitant disease
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Israel20 sites
Study site
Afula, 18101
Study site
Ashkelon, 78278
Study site
Bat Yam
Study site
Beersheba, 84105
Study site
Hadera, 38100
Study site
Haifa, 31096
Study site
Haifa, 33394
Study site
Haifa, 34362
Study site
Holon, 58100
Study site
Jerusalem, 91120
Study site
Kfar Saba, 44281
Study site
Nahariya, 22100
Study site
Nazareth
Study site
Petah Tikva, 49100
Study site
Petah Tikva
Study site
Ramat Gan, 52621
Study site
Rehovot, 76100
Study site
Safed, 13110
Study site
Tel Aviv, 6423906
Study site
Tsrifin, 6093000
About this study
Official title: Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C
This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Copegus (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.
Copegus (ribavirin)Drug
800 - 1200 mg po daily for 24 weeks
Copegus (ribavirin)Drug
800 - 1200 mg po daily for 48 weeks
peginterferon alfa-2a [Pegasys]Drug
180 mcg sc once weekly for 24 weeks
peginterferon alfa-2a [Pegasys]Drug
180 mcg sc once weekly for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Copegus (ribavirin); Drug: peginterferon alfa-2a [Pegasys] |
| B | Experimental | Not described Receives: Drug: Copegus (ribavirin); Drug: peginterferon alfa-2a [Pegasys] |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability with regard to clinical AEs and laboratory parameters
Measured: assessed every 2 weeks throughout study and after 8 weeks follow-up
Secondary outcomes (1)
safety with regard to hematological parameters
Measured: assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startOct 2002
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,695 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
- NCT00940420
- Sponsor's protocol ID
- ML16837
- Status last verified
- Nov 2016
- First submitted
- 6 Jul 2009
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00940420
- Acronym / sponsor ID
- ML16837
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,695 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Copegus (ribavirin), Drug: peginterferon alfa-2a [Pegasys] |
| B | Experimental | Drug: Copegus (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 (4 listed)
- adult patients >/= 18 years of age
- serologic evidence of chronic hepatitis C infection
- compensated liver disease
- negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment
Key exclusion criteria (4 listed)
- history or other evidence of a medical condition associated with chronic liver disease other than HCV
- hepatitis A, hepatitis B or HIV infection
- hepatocellular carcinoma
- severe concomitant 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 |
|---|---|---|
| Copegus (ribavirin)800 - 1200 mg po daily for 24 weeks | Drug | A |
| Copegus (ribavirin)800 - 1200 mg po daily for 48 weeks | Drug | B |
| peginterferon alfa-2a [Pegasys]180 mcg sc once weekly for 24 weeks | Drug | A |
| peginterferon alfa-2a [Pegasys]180 mcg sc once weekly for 48 weeks | Drug | B |
Primary outcome
safety and tolerability with regard to clinical AEs and laboratory parameters
Time frame: assessed every 2 weeks throughout study and after 8 weeks follow-up
1 secondary outcome
safety with regard to hematological parameters
Time frame: assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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 (ribavirin) 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 4 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 2 Nov 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
safety and tolerability with regard to clinical AEs and laboratory parameters (time frame: assessed every 2 weeks throughout study and after 8 weeks follow-up). 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 2 Nov 2016.