Chronic Hepatitis CPhase 3NCT01263860
A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for HCV Genotype-6 Patients
A Phase 3 study testing Peginterferon alfa2a and Ribavirin in people with Chronic Hepatitis C, run by Third Affiliated Hospital, Sun Yat-Sen University at 4 sites in China.
Trial summary
Patients with HCV genotype 6 infection who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Peginterferon alfa2a and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 4 sitesChina
- Study dates
- Dec 2010to 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCV RNA is positive
- Genotype 6
- Treatment naive
- Raised ALT
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
4 sites in 1 country.
China4 sites
The Eighth People's Hospital of Guangzhou
Guangzhou, Guangdong, 510060
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Panyu People's Hospital
Guangzhou, Guangdong
Zhongshan second people's hospital
Zhongshan, Guangdong
About this study
Official title: A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus
Patients with HCV genotype 6 infection who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.
Read the detailed description
High rate of infection of Hepatitis C Virus(HCV) Genotype 6 was recently confirmed in Southern China. Recent study implied chronic hepatitis C genotype 6 responds better to the 48-week treatment with pegylated interferon and ribavirin than genotype 1. Approximately 75.7% obtain sustained virological response (HCV RNA undetectable 24 weeks after treatment) to this approach. However, the treatment is associated with many and sometimes serious side effects. In addition, the treatment is costly also in economical terms. Shorter treatment for chronic hepatitis C genotype 6 is necessary to be assessed.
In this randomised,open label,multicenter phase 3 trial with active controls patients are treated with pegylated interferon alfa 2a (180ug/week)and ribavirin(800-1200mg based on weight)for 4 weeks. Those who are HCV RNA negative at week 4 (<50 IU; Cobas Amplicor Monitor Test, Roche Diagnostic) are defined as rapid virological responders and randomised to either an additional 20 or 44 weeks combination treatment. Patients who are HCV RNA positive are all treated for 44 more weeks. The endpoint is sustained virological response defined as undetectable HCV RNA 24 weeks after end of treatment.
Our hypothesis is that there is no important difference in the effect in the two groups.
This is a non-inferiority trial. The smallest difference considered to be clinically important is 15%. Thus to state "non-inferiority" the 95% confidence interval of the observed difference between the groups shall not overlap 10%. Both intention to treat and and per protocol analyses will be published. Conclusion will be conservative and based on the analysis who detect the biggest difference.
- Conditions
- Chronic Hepatitis C
- Being tested
- Peginterferon alfa2a, 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 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
Peginterferon alfa2aDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 24-Week treatment group | Experimental | Genotype 6 chronic hepatitis C patients with rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 20 weeks Receives: Drug: Peginterferon alfa2a; Drug: Ribavirin |
| 48-Week treatment group | Active comparator | Genotype 6 chronic hepatitis C patients with rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 44 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 from 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 posted21 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 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
- Investigators
- Gao Zhiliang, Doctor, Study chair, The Third Affliated Hospital of Sun Yat-sen UniversityZhao Zhixin, Doctor, Study director, The Third Affliated Hospital of Sun Yat-sen UniversityZhang Xiaohong, Doctor, Principal investigator, The Third Affliated Hospital of Sun Yat-sen UniversityXu Min, Doctor, Principal investigator, The Eighth People's Hospital of GuangzhouWei min, Doctor, Principal investigator, Zhongshan second people's hospitalHuang mingshou, Bachelor, Principal investigator, Panyu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263860
- Sponsor's protocol ID
- TAH115G6HCV
- Status last verified
- Nov 2014
- First submitted
- 20 Dec 2010
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cai Q, Zhang X, Lin C, Shao X, Guan Y, Deng H, Wei M, Huang M, Ren Z, Lu L, Mei Y, Xu M, Zhu J, Shi H, Lin G, Liu Y, Hu F, Luo Q, Lan Y, Guo F, Zhao Z, Gao Z. 24 versus 48 Weeks of Peginterferon Plus Ribavirin in Hepatitis C Virus Genotype 6 Chronically Infected Patients with a Rapid Virological Response: A Non-Inferiority Randomized Controlled Trial. PLoS One. 2015 Oct 28;10(10):e0140853. doi: 10.1371/journal.pone.0140853. eCollection 2015.
PubMed 26509605
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
- A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus
- ClinicalTrials.gov ID
- NCT01263860
- Acronym / sponsor ID
- TAH115G6HCV
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Dec 2010 (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.
Patients with HCV genotype 6 infection who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.
Detailed description
High rate of infection of Hepatitis C Virus(HCV) Genotype 6 was recently confirmed in Southern China. Recent study implied chronic hepatitis C genotype 6 responds better to the 48-week treatment with pegylated interferon and ribavirin than genotype 1. Approximately 75.7% obtain sustained virological response (HCV RNA undetectable 24 weeks after treatment) to this approach. However, the treatment is associated with many and sometimes serious side effects. In addition, the treatment is costly also in economical terms. Shorter treatment for chronic hepatitis C genotype 6 is necessary to be assessed.
In this randomised,open label,multicenter phase 3 trial with active controls patients are treated with pegylated interferon alfa 2a (180ug/week)and ribavirin(800-1200mg based on weight)for 4 weeks. Those who are HCV RNA negative at week 4 (<50 IU; Cobas Amplicor Monitor Test, Roche Diagnostic) are defined as rapid virological responders and randomised to either an additional 20 or 44 weeks combination treatment. Patients who are HCV RNA positive are all treated for 44 more weeks. The endpoint is sustained virological response defined as undetectable HCV RNA 24 weeks after end of treatment.
Our hypothesis is that there is no important difference in the effect in the two groups.
This is a non-inferiority trial. The smallest difference considered to be clinically important is 15%. Thus to state "non-inferiority" the 95% confidence interval of the observed difference between the groups shall not overlap 10%. Both intention to treat and and per protocol analyses will be published. Conclusion will be conservative and based on the analysis who detect the biggest difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24-Week treatment group | Experimental | Drug: Peginterferon alfa2a, Drug: RibavirinGenotype 6 chronic hepatitis C patients with rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 20 weeks |
| 48-Week treatment group | Active comparator | Drug: Peginterferon alfa2a, Drug: RibavirinGenotype 6 chronic hepatitis C patients with rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 44 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HCV RNA is positive
- Genotype 6
- Treatment naive
- Raised ALT
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 |
|---|---|---|
| Peginterferon alfa2apatients receive a dose of 180 µg of PEGASYS once a week for 24 weeks | Drug | 24-Week treatment group |
| Ribavirinpatients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks | Drug | 24-Week treatment group |
| Peginterferon alfa2apatients receive a dose of 180 µg of PEGASYS once a week for 48 weeks | Drug | 48-Week treatment group |
| Ribavirinpatients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks | Drug | 48-Week treatment group |
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 from 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.
- Derived from this study: PubMed 26509605Cai Q, Zhang X, Lin C, Shao X, Guan Y, Deng H, Wei M, Huang M, Ren Z, Lu L, Mei Y, Xu M, Zhu J, Shi H, Lin G, Liu Y, Hu F, Luo Q, Lan Y, Guo F, Zhao Z, Gao Z. 24 versus 48 Weeks of Peginterferon Plus Ribavirin in Hepatitis C Virus Genotype 6 Chronically Infected Patients with a Rapid Virological Response: A Non-Inferiority Randomized Controlled Trial. PLoS One. 2015 Oct 28;10(10):e0140853. doi: 10.1371/journal.pone.0140853. eCollection 2015.
Related trials for Chronic Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
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.
Gao Zhiliang, Doctor study chair
The Third Affliated Hospital of Sun Yat-sen University
Zhao Zhixin, Doctor study director
The Third Affliated Hospital of Sun Yat-sen University
Zhang Xiaohong, Doctor principal investigator
The Third Affliated Hospital of Sun Yat-sen University
4 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 Peginterferon alfa2a and Ribavirin in people with Chronic Hepatitis C, run by Third Affiliated Hospital, Sun Yat-Sen University at 4 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 4 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 4 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?
On the ClinicalTrials.gov record for NCT01263860, 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 18 Nov 2014.