Hepatitis C, ChronicPhase 4NCT00279565
Buprenorphine Versus Methadone Maintenance in Hepatitis C Patients Receiving Peg-Intron and Rebetol (Study P04279)(TERMINATED)
A Phase 4 study testing buprenorphine, methadone and pegylated interferon alfa-2b plus ribavirin in people with Hepatitis C, Chronic, run by Indivior Inc..
Trial summary
This randomized, single-center, controlled study is designed to evaluate the safety, tolerability, and efficacy of treatment with Peg-Intron with Rebetol in methadone or buprenorphine maintenance patients with hepatitis C. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- buprenorphine, methadone and pegylated interferon alfa-2b plus ribavirin
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Feb 2007
- 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
- Male and female patients with a history of intravenous drug abuse, who are willing to undergo methadone or buprenorphine substitution.
- Patients with newly diagnosed chronic hepatitis C.
- Age 18-65.
- Hepatitis C virus (HCV)-ribonucleic acid (RNA) positive in serum as measured by polymerase chain reaction (PCR) within the last 4 weeks.
- Genotype 2 or 3.
- Elevated alanine aminotransferase (ALT) levels.
Show all 18Show fewer
- In women of child-bearing age, pregnancy must be excluded prior to entry into the study, and the use of a safe contraceptive device (intrauterine device, oral contraceptive, diaphragm + spermicide, condom + spermicide, tubal ligation) must be documented.
- Lab parameters:
- Hemoglobin: >=12 g/dL (women) or >=13 g/dL (men)
- Leukocytes >=3,000/µL
- Thrombocytes >=100,000/µL
- Prothrombin time (PT)/partial thromboplastin time (PTT)/coagulation within the normal range
- Albumin: not more than 10% deviation from lower normal value
- Thyroid-stimulating hormone (TSH) normal
- Creatinine normal
- Uric acid normal
- Antinuclear antibodies <=1:160
- Signed informed consent.
Who cannot join
- Refusal by women of child-bearing age or by sexually active patients to use a safe contraceptive.
- Breast-feeding women.
- Cirrhosis stage B and C according to Child-Pugh.
- Signs of decompensated liver disease (ascites, bleeding varices and spontaneous encephalopathy).
- Confirmed co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV).
- Existing psychiatric comorbidity.
Show all 15Show fewer
- Alcohol abuse.
- Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
- Existing psoriasis or other dermatological disorder (relative exclusion criterion: due to great differences with regard to the severity of the disorder and the individual therapy compatibility, the therapy decision is at the discretion of the physician).
- Treatment with a study drug within the last 30 days.
- Any uncontrolled underlying medical conditions (e.g. diabetes).
- Clinically significant electrocardiogram (ECG) abnormalities and / or significant cardiovascular dysfunction within the last 6 months (angina, heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia) is an exclusion criterion. In case of other suspected heart disease, a cardiologic examination is required prior to inclusion of the patient.
- Any liver disorder of other genesis than the study indication (with regard to elevated iron levels, only patients with manifest hemochromatosis are excluded).
- Autoimmune disorder (except LKM-positive patients: these patients may be included in the study).
- Misuse of buprenorphine or methadone.
About this study
Official title: Randomized, Controlled Study of Buprenorphine and Methadone in Hepatitis C Patients in Need of Treatment
This randomized, single-center, controlled study is designed to evaluate the safety, tolerability, and efficacy of treatment with Peg-Intron with Rebetol in methadone or buprenorphine maintenance patients with hepatitis C.
- Conditions
- Hepatitis C, Chronic
- Being tested
- buprenorphine, methadone, pegylated interferon alfa-2b plus ribavirin
- Keywords
- buprenorphine, methadone, Peg-Intron, Rebetol
- 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.
buprenorphineDrug
methadoneDrug
pegylated interferon alfa-2b plus ribavirinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startAug 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: The trial was terminated because of deviations from the protocol.
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.
- 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
- 128 participants
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AESCA Pharma GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279565
- Sponsor's protocol ID
- P04279
- Status last verified
- Feb 2007
- First submitted
- 17 Jan 2006
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Study of Buprenorphine and Methadone in Hepatitis C Patients in Need of Treatment
- ClinicalTrials.gov ID
- NCT00279565
- Acronym / sponsor ID
- P04279
- Conditions
- Hepatitis C, Chronic
- Keywords
- buprenorphine, methadone, Peg-Intron, Rebetol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated because of deviations from the protocol.
- Enrolment
- 128 participants
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Collaborators
- AESCA Pharma GmbH
- Study start
- Aug 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 19 Jan 2006 (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 randomized, single-center, controlled study is designed to evaluate the safety, tolerability, and efficacy of treatment with Peg-Intron with Rebetol in methadone or buprenorphine maintenance patients with hepatitis C.
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 (18 listed)
- Male and female patients with a history of intravenous drug abuse, who are willing to undergo methadone or buprenorphine substitution.
- Patients with newly diagnosed chronic hepatitis C.
- Age 18-65.
- Hepatitis C virus (HCV)-ribonucleic acid (RNA) positive in serum as measured by polymerase chain reaction (PCR) within the last 4 weeks.
- Genotype 2 or 3.
Key exclusion criteria (15 listed)
- Refusal by women of child-bearing age or by sexually active patients to use a safe contraceptive.
- Breast-feeding women.
- Cirrhosis stage B and C according to Child-Pugh.
- Signs of decompensated liver disease (ascites, bleeding varices and spontaneous encephalopathy).
- Confirmed co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV).
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 |
|---|---|---|
| buprenorphine | Drug | – |
| methadone | Drug | – |
| pegylated interferon alfa-2b plus ribavirin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: The trial was terminated because of deviations from the protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
Related trials for Hepatitis C, Chronic
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing buprenorphine, methadone and pegylated interferon alfa-2b plus ribavirin in people with Hepatitis C, Chronic, run by Indivior Inc..
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 18 inclusion and 15 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: stopped early, as of the sponsor's last update on 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: The trial was terminated because of deviations from the protocol.). Results are not available in the source record.
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.
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 22 Nov 2012.