Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Non-responders
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C Genotype 3 Non-responders Relapsers |
Drug: interferon alpha-2b, ribavirin, interferon-gamma, Drug: interferon alpha-2b, ribavirin, amantadine |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Patients Who Are Non-responders to Interferon Alpha Plus Ribavirin |
| Estimated Enrollment: | 40 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Interferon alpha, ribavirin, interferon gamma
|
Drug: interferon alpha-2b, ribavirin, interferon-gamma, |
|
Active Comparator: 2
Interferon alpha, ribavirin, amantadine
|
Drug: interferon alpha-2b, ribavirin, amantadine |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- ≥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
Exclusion Criteria:
- 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.
- 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
Contacts and Locations| Pakistan | |
| The Aga Khan University Hospital | |
| Karachi, Pakistan, 74800 | |
| Medicare Clinic | |
| Karachi, Pakistan, 74800 | |
| Principal Investigator: | Zaigham Abbas, FCPS, FACG | The Aga Khan University Hospital |
More Information
No publications provided by Aga Khan University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00538811 History of Changes |
| Other Study ID Numbers: | 648-Med |
| Study First Received: | October 2, 2007 |
| Last Updated: | October 26, 2010 |
| Health Authority: | Pakistan: Research Ethics Committee |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2a Amantadine Interferon Alfa-2b |
Interferon-gamma Interferons Ribavirin Reaferon Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013