Chronic Hepatitis CPhase 3NCT01441804
A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism
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 1 and IL28B CC Polymorphism 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 16 to 65 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
- 200 participants
- Where
- 4 sitesChina
- Study dates
- May 2011to Aug 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
- Age > 18 years
- Serum Hepatitis C RNA > 10,000IU/mL
- Hepatitis C virus genotype 1
- IL28B CC polymorphism
Who cannot join
- Previous treatment for chronic Hepatitis C
- clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml
- HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease
- Contraindications to PR-based treatment:
- Uncontrolled psychiatric illness
- Active substance dependency
Show all 19Show fewer
- Known autoimmune disorder
- Untreated thyroid disease
- Uncontrolled seizure disorder
- Pregnancy, lactation or inability to maintain contraception
- Chronic kidney disease w/ estimated GFR< 60
- ANC<1.5/nl, Hb<12g/dl, or platelets<75/nl
- Clinical or biochemical evidence of decompensated liver disease including:
- History of encephalopathy
- Ascites
- Variceal bleeding
- Bilirubin > 3g/dl or INR > 1.5
- Life threatening disorder with expected median survival less than 5 years
- Inability to comply with drug regimens or testing schedule required for study
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
The Eighth People's Hospital of Guangzhou
Guangzhou, Guangdong, 510630
Chen Fengjuan, Doctor, 13416167557, fengjuandj@163.com
Xu Min, doctor
- Recruiting
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Cai Qingxian, doctor, 13760857996, Cqx200000@163.com
Zhang Xiaohong, Doctor
- Recruiting
Panyu People's Hospital
Guangzhou, Guangdong
Huang mingshou, Bachelor, +86013711033556
Huang mingshou, Bachelor
- Recruiting
Zhongshan second people's hospital
Zhongshan, Guangdong
Wei min, Doctor, +86013702528182
Wei min, doctor
About this study
Patients with HCV genotype 1 and IL28B CC Polymorphism 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.
- 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 1 chronic hepatitis C patients with IL28B CC Polymorphism and 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 1 chronic hepatitis C patients with IL28B CC Polymorphism and 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: baseline, 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 posted28 Sep 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2014 (estimated)
- Study completionAug 2014 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441804
- Sponsor's protocol ID
- TAHG1IL-28BCC
- Status last verified
- Sep 2013
- First submitted
- 24 Sep 2011
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. 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 Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism
- ClinicalTrials.gov ID
- NCT01441804
- Acronym / sponsor ID
- TAHG1IL-28BCC
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 28 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.
Patients with HCV genotype 1 and IL28B CC Polymorphism 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.
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 1 chronic hepatitis C patients with IL28B CC Polymorphism and 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 1 chronic hepatitis C patients with IL28B CC Polymorphism and 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
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Serum Hepatitis C RNA > 10,000IU/mL
- Hepatitis C virus genotype 1
- IL28B CC polymorphism
Key exclusion criteria (19 listed)
- Previous treatment for chronic Hepatitis C
- clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml
- HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease
- Contraindications to PR-based treatment:
- Clinical or biochemical evidence of decompensated liver disease including:
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: baseline, 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
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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.
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 19 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: status not confirmed, as of the sponsor's last update on 1 Oct 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cai Qingxian, doctor (+86013760857996, cqx200000@163.com), or a site near the patient. 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 1 Oct 2013.