Chronic Hepatitis CPhase 3NCT01433887
Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic Hepatitis C Genotypes 1 Versus 2/3 Versus 6
A Phase 3 study testing 48-weeks course, Ribavirin and Peginterferon alfa2a in people with Chronic Hepatitis C, run by Third Affiliated Hospital, Sun Yat-Sen University at 3 sites in China.
Trial summary
The Chinese patients with chronic hepatitis C have a different genetic background, which had been demonstrated to significantly influence their responses to pegylated interferon and ribavirin. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- 48-weeks course, Ribavirin and Peginterferon alfa2a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 535 participants
- Where
- 3 sitesChina
- Study dates
- Nov 2011to Jun 2014
- Phase
- Phase 3
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HCV RNA is positive
- Treatment naive
- Come from China
Who cannot join
- Active substance abuse
- Poorly controlled psychiatric disease
- HBsAg positive
- Anti-HIV positive
- Suffering from other significant concurrent medical conditions including chronic liver diseases
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Eighth People's Hospital of Guangzhou
Guangzhou, Guangdong, 510000
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Zhongshan second people's hospital
Zhongshan, Guangdong
About this study
Official title: Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic
The Chinese patients with chronic hepatitis C have a different genetic background, which had been demonstrated to significantly influence their responses to pegylated interferon and ribavirin. In this study, Chinese patients with Hepatitis C Virus genotype 1, 2/3, 6 infection were treated with pegylated interferon and ribavirin. Their response was compared amongst different genotypes.
- Conditions
- Chronic Hepatitis C
- Being tested
- 48-weeks course, Ribavirin, Peginterferon alfa2a
- Keywords
- 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.
48-weeks courseDrug
patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
RibavirinDrug
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks
Peginterferon alfa2aDrug
patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
RibavirinDrug
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Genotype 6 | Experimental | Genotype 6 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks Receives: Drug: 48-weeks course; Drug: Ribavirin |
| Genotype 1 | Experimental | Genotype 1 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks Receives: Drug: 48-weeks course; Drug: Ribavirin |
| Genotype 2/3 | Experimental | Genotype 2/3 chronic hepatitis C patients will be treated with Peginterferon alfa-2a/2b plus ribavirin for 24 weeks Receives: Drug: Peginterferon alfa2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response (SVR)
Undetectable HCVRNA in serum(<15IU/ml) 24 weeks after the end of treatment
Measured: 24 weeks after the end of treatment
Secondary outcomes (2)
Change in health related quality as measured by short form 36 (SF-36) from baseline to 24 weeks after the end of treatment
Measured: 24 weeks after the end of treatment
Sick leave in patients treated for 24 or 48 weeks treatment
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai Qingxian, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433887
- Sponsor's protocol ID
- TAH5010G6HCV
- Status last verified
- Nov 2014
- First submitted
- 11 Sep 2011
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic
- ClinicalTrials.gov ID
- NCT01433887
- Acronym / sponsor ID
- TAH5010G6HCV
- Conditions
- Chronic Hepatitis C
- Keywords
- Peginterferon alfa-2a, ribavirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Sep 2011 (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.
The Chinese patients with chronic hepatitis C have a different genetic background, which had been demonstrated to significantly influence their responses to pegylated interferon and ribavirin. In this study, Chinese patients with Hepatitis C Virus genotype 1, 2/3, 6 infection were treated with pegylated interferon and ribavirin. Their response was compared amongst different genotypes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Genotype 6 | Experimental | Drug: 48-weeks course, Drug: RibavirinGenotype 6 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks |
| Genotype 1 | Experimental | Drug: 48-weeks course, Drug: RibavirinGenotype 1 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks |
| Genotype 2/3 | Experimental | Drug: Peginterferon alfa2a, Drug: RibavirinGenotype 2/3 chronic hepatitis C patients will be treated with Peginterferon alfa-2a/2b plus ribavirin for 24 weeks |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- HCV RNA is positive
- Treatment naive
- Come from China
Key exclusion criteria (5 listed)
- Active substance abuse
- Poorly controlled psychiatric disease
- HBsAg positive
- Anti-HIV positive
- Suffering from other significant concurrent medical conditions including chronic liver diseases
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 |
|---|---|---|
| 48-weeks coursepatients receive a dose of 180 µg of PEGASYS once a week for 48 weeks | Drug | Genotype 1, Genotype 6 |
| Ribavirinpatients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks | Drug | Genotype 1, Genotype 6 |
| Peginterferon alfa2apatients receive a dose of 180 µg of PEGASYS once a week for 24 weeks | Drug | Genotype 2/3 |
| Ribavirinpatients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks | Drug | Genotype 2/3 |
Primary outcome
Sustained virological response (SVR)
Time frame: 24 weeks after the end of treatment
Undetectable HCVRNA in serum(<15IU/ml) 24 weeks after the end of treatment
2 secondary outcomes
Change in health related quality as measured by short form 36 (SF-36) from baseline to 24 weeks after the end of treatment
Time frame: 24 weeks after the end of treatment
Sick leave in patients treated for 24 or 48 weeks treatment
Time frame: 48 weeks
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 18 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 48-weeks course, Ribavirin and Peginterferon alfa2a in people with Chronic Hepatitis C, run by Third Affiliated Hospital, Sun Yat-Sen University at 3 sites in China.
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 3 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 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
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?
Sustained virological response (SVR) (time frame: 24 weeks after the end of treatment). 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 18 Nov 2014.