Hepatitis CPhase 2/3NCT00538811
Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Non-responders
A Phase 2/3 study testing interferon alpha-2b, ribavirin, interferon-gamma, and interferon alpha-2b, ribavirin, amantadine in people with Hepatitis C and Genotype 3, run by Aga Khan University at 2 sites in Pakistan.
Trial summary
When administered simultaneously, interferon-alpha 2b + interferon-gamma result in dramatic antiviral synergy.Ribavirin has shown to enhance interferon-gamma levels in patients with chronic hepatitis C treated with interferon-alpha. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Genotype 3, Non-responders
- What is being tested?
- interferon alpha-2b, ribavirin, interferon-gamma, and interferon alpha-2b, ribavirin, amantadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesPakistan
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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
- Non-responders and relapsers to previous interferon and ribavirin therapy given for six months
- HCV genotype 3
- Compensated liver disease
- Hb ≥10 g/dl (females),≥11 g/dl (males)
- Platelets count ≥ 100,000 / cubic mm
- Neutrophils count ≥1,500/cubic mm
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- ≥18 years to ≤ 70 years.
- At least one abnormal ALT value in the last year.
- TSH level within normal limits.
- Non pregnant adult females.
- Absence of drug or alcohol abuse.
- Informed consent given by the patient
Who cannot join
- Patient younger than 18 yrs and older than 70 yrs.
- Hepatitis B or HIV co-infection.
- Severe renal dysfunction or creatinine clearance less than 50 ml/min
- Pregnant women or breast feeding women.
- Suspected hypersensitivity to Interferon alpha, gamma or ribavirin.
- Decompensated liver cirrhosis.
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- History or any other evidence of other causes of CLD other than hepatitis C infection ( like hemochromatosis,, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure, Wilson's disease,Drug induced liver disease)
- Active malignant disease.
- Any known pre-existing medical condition that could interfere with subject's participation or completion of study such as psychiatric condition, seizures disorder requiring medications, co existing heart diseases, lung diseases, poorly controlled diabetes, auto immune diseases, gout)
- History of interferon and/or ribavirin intolerance
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Medicare Clinic
Karachi, 74800
The Aga Khan University Hospital
Karachi, 74800
About this study
Official title: Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Patients Who Are Non-responders to Interferon Alpha Plus Ribavirin
When administered simultaneously, interferon-alpha 2b + interferon-gamma result in dramatic antiviral synergy.Ribavirin has shown to enhance interferon-gamma levels in patients with chronic hepatitis C treated with interferon-alpha. Enhancement of immune responses, especially those related to type-1 T helper cell activity, may contribute to better efficacy in combining ribavirin with IFN-alpha for treatment of chronic hepatitis C. The aim of the present study is to evaluate the efficacy and safety of a triple regimen, a combination treatment with Interferon gamma, Interferon alfa-2b plus Ribavirin in patients who have not previously responded to interferon alpha in combination of ribavirin.
- Conditions
- Hepatitis C, Genotype 3, Non-responders, Relapsers
- Being tested
- interferon alpha-2b, ribavirin, interferon-gamma,, interferon alpha-2b, ribavirin, amantadine
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon alpha-2b, ribavirin, interferon-gamma,Drug
interferon alpha-2b, ribavirin, amantadineDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Interferon alpha, ribavirin, interferon gamma Receives: Drug: interferon alpha-2b, ribavirin, interferon-gamma, |
| 2 | Active comparator | Interferon alpha, ribavirin, amantadine Receives: Drug: interferon alpha-2b, ribavirin, amantadine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
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 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Zaigham Abbas, FCPS, FACG, Principal investigator, The Aga Khan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538811
- Sponsor's protocol ID
- 648-Med
- Status last verified
- Oct 2010
- First submitted
- 2 Oct 2007
- Last updated
- 27 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abbas Z, Raza S, Hamid S, Jafri W. Randomized controlled trial of interferon gamma versus amantadine in combination with interferon alpha and ribavirin for hepatitis C genotype 3 non-responders and relapsers. J Pak Med Assoc. 2012 Apr;62(4):338-43.
PubMed 22755276
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Patients Who Are Non-responders to Interferon Alpha Plus Ribavirin
- ClinicalTrials.gov ID
- NCT00538811
- Acronym / sponsor ID
- 648-Med
- Conditions
- Hepatitis C, Genotype 3, Non-responders, Relapsers
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- First posted
- 3 Oct 2007 (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.
When administered simultaneously, interferon-alpha 2b + interferon-gamma result in dramatic antiviral synergy.Ribavirin has shown to enhance interferon-gamma levels in patients with chronic hepatitis C treated with interferon-alpha. Enhancement of immune responses, especially those related to type-1 T helper cell activity, may contribute to better efficacy in combining ribavirin with IFN-alpha for treatment of chronic hepatitis C. The aim of the present study is to evaluate the efficacy and safety of a triple regimen, a combination treatment with Interferon gamma, Interferon alfa-2b plus Ribavirin in patients who have not previously responded to interferon alpha in combination of ribavirin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: interferon alpha-2b, ribavirin, interferon-gamma,Interferon alpha, ribavirin, interferon gamma |
| 2 | Active comparator | Drug: interferon alpha-2b, ribavirin, amantadineInterferon alpha, ribavirin, amantadine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Non-responders and relapsers to previous interferon and ribavirin therapy given for six months
- HCV genotype 3
- Compensated liver disease
- Hb ≥10 g/dl (females),≥11 g/dl (males)
- Platelets count ≥ 100,000 / cubic mm
Key exclusion criteria (10 listed)
- Patient younger than 18 yrs and older than 70 yrs.
- Hepatitis B or HIV co-infection.
- Severe renal dysfunction or creatinine clearance less than 50 ml/min
- Pregnant women or breast feeding women.
- Suspected hypersensitivity to Interferon alpha, gamma or ribavirin.
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 |
|---|---|---|
| interferon alpha-2b, ribavirin, interferon-gamma, | Drug | 1 |
| interferon alpha-2b, ribavirin, amantadine | Drug | 2 |
Primary outcome
Not reported in the source record.
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 27 Oct 2010.
- Derived from this study: PubMed 22755276Abbas Z, Raza S, Hamid S, Jafri W. Randomized controlled trial of interferon gamma versus amantadine in combination with interferon alpha and ribavirin for hepatitis C genotype 3 non-responders and relapsers. J Pak Med Assoc. 2012 Apr;62(4):338-43.
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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.
Zaigham Abbas, FCPS, FACG principal investigator
The Aga Khan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing interferon alpha-2b, ribavirin, interferon-gamma, and interferon alpha-2b, ribavirin, amantadine in people with Hepatitis C and Genotype 3, run by Aga Khan University at 2 sites in Pakistan.
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 12 inclusion and 10 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 27 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00538811, 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 27 Oct 2010; AzTrials last refreshed its copy on 31 Oct 2026.