Chronic Hepatitis C, HCV Genotype 1Phase 4NCT00152581
Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication
A Phase 4 study testing Pegylated interferon-alfa2a (Pegasys); ribavirin in people with Chronic Hepatitis C, HCV Genotype 1, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
Open-label, single centre study evaluating efficacy and viral kinetics of combination PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral clearance demonstrated between 4 - 12 weeks, then randomised to further continued combination treatment for one of three defined durations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C, HCV Genotype 1
- What is being tested?
- Pegylated interferon-alfa2a (Pegasys); ribavirin
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2002to not given
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 65
- HCV RNA positive
- HCV genotype 1
- Histologically proven chronic hepatitis
- No previous antiviral treatment
Who cannot join
- Liver histology showing cirrhosis
- Decompensated liver function
- WCC < 1500/mm3 or platelet count <90,000/mm3
- Co-infection with HIV or HBV/HAV
- Alcohol intake greater than 40 units/week
- Current intravenous drug dependence
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- Pregnancy or breast feeding of infants
- Inadequate contraception
- Neuropsychiatric disorder
- Neoplastic disease
- Other significant medical problems
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hepatitis Clinic
University College London Hospital, London, WC1E 6HX
About this study
Open-label, single centre study evaluating efficacy and viral kinetics of combination PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral clearance demonstrated between 4 - 12 weeks, then randomised to further continued combination treatment for one of three defined durations. Followed-up for 24 weeks after treatment cessation.
Objectives:
- To determine the necessary duration of combination treatment with Pegylated-Interferon alfa2a (PEGASYS) \& Ribavirin in Patients infected with genotype 1, in order to achieve viral clearance
- To identify host factors, which are associated with different patterns of virological response to combination treatment (fast responder, slow responder, non-responder). On this basis, to identify possible predictors for the duration of antiviral treatment.
Read the detailed description
Forty treatment-naïve patients with chronic hepatitis C, all infected with genotype 1, will be entered into this study. All 40 patients will be started on the same regimen of 180mg Pegylated-Interferon alfa2a (PEGASYS) weekly plus Ribavirin 1000-1200mg daily. HCV RNA in the serum will be monitored by qualitative PCR at treatment weeks 4, 8 and 12. Patients who become HCV RNA negative at any of the above time-points (4,8 or 12), will be randomised into one of three groups to continue the same antiviral regimen for an additional 3 month, 6 month or 9 month period. All these patients will subsequently be followed-up and monitored for a further 6 months after stopping all antiviral treatment.
Treatment will be discontinued for patients who remain persistently HCV RNA positive at treatment week 12 and they will be withdrawn from the study protocol.
- Conditions
- Chronic Hepatitis C, HCV Genotype 1
- Being tested
- Pegylated interferon-alfa2a (Pegasys); ribavirin
- Keywords
- HCV, genotype 1, treatment, HCV kinetics, T-cells
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated interferon-alfa2a (Pegasys); ribavirinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response (HCV RNA negative) 6 months post-treatment cessation
Secondary outcomes (2)
Hepatic and serum HCV RNA levels as a predictor for treatment duration
HCV-specific T-cell reactivity as a predictor for treatment duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C, HCV Genotype 1Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Investigators
- Nikolai V. Naoumov, MD, Principal investigator, Institute of Hepatology, University College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152581
- Sponsor's protocol ID
- 01/0277
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 1 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication
- ClinicalTrials.gov ID
- NCT00152581
- Acronym / sponsor ID
- 01/0277
- Conditions
- Chronic Hepatitis C, HCV Genotype 1
- Keywords
- HCV, genotype 1, treatment, HCV kinetics, T-cells
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Apr 2002
- First posted
- 9 Sep 2005 (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.
Open-label, single centre study evaluating efficacy and viral kinetics of combination PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral clearance demonstrated between 4 - 12 weeks, then randomised to further continued combination treatment for one of three defined durations. Followed-up for 24 weeks after treatment cessation.
Objectives:
- To determine the necessary duration of combination treatment with Pegylated-Interferon alfa2a (PEGASYS) \& Ribavirin in Patients infected with genotype 1, in order to achieve viral clearance
- To identify host factors, which are associated with different patterns of virological response to combination treatment (fast responder, slow responder, non-responder). On this basis, to identify possible predictors for the duration of antiviral treatment.
Detailed description
Forty treatment-naïve patients with chronic hepatitis C, all infected with genotype 1, will be entered into this study. All 40 patients will be started on the same regimen of 180mg Pegylated-Interferon alfa2a (PEGASYS) weekly plus Ribavirin 1000-1200mg daily. HCV RNA in the serum will be monitored by qualitative PCR at treatment weeks 4, 8 and 12. Patients who become HCV RNA negative at any of the above time-points (4,8 or 12), will be randomised into one of three groups to continue the same antiviral regimen for an additional 3 month, 6 month or 9 month period. All these patients will subsequently be followed-up and monitored for a further 6 months after stopping all antiviral treatment.
Treatment will be discontinued for patients who remain persistently HCV RNA positive at treatment week 12 and they will be withdrawn from the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 - 65
- HCV RNA positive
- HCV genotype 1
- Histologically proven chronic hepatitis
- No previous antiviral treatment
Key exclusion criteria (11 listed)
- Liver histology showing cirrhosis
- Decompensated liver function
- WCC < 1500/mm3 or platelet count <90,000/mm3
- Co-infection with HIV or HBV/HAV
- Alcohol intake greater than 40 units/week
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 |
|---|---|---|
| Pegylated interferon-alfa2a (Pegasys); ribavirin | Drug | – |
Primary outcome
Sustained virological response (HCV RNA negative) 6 months post-treatment cessation
2 secondary outcomes
Hepatic and serum HCV RNA levels as a predictor for treatment duration
HCV-specific T-cell reactivity as a predictor for treatment duration
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 1 Dec 2005.
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.
Nikolai V. Naoumov, MD principal investigator
Institute of Hepatology, University College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegylated interferon-alfa2a (Pegasys); ribavirin in people with Chronic Hepatitis C, HCV Genotype 1, run by University College London Hospitals at 1 site in United Kingdom.
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 5 inclusion and 11 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 1 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Sustained virological response (HCV RNA negative) 6 months post-treatment cessation. 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 Dec 2005.