Clinical Trial to Assess Safety and Efficacy of Combination Therapy: Hydroxychloroquine, Pegylated Interferon Alpha-2a and Ribavirin in Chronic Hepatitis C Subjects Non-responders to the Standard of Care Therapy.
Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis C
Intervention: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and Ribavirin (Biological)
Phase: Phase 1/Phase 2
Status: Not yet recruiting
Sponsored by: Sheba Medical Center Overall contact: Yaakov Maor, Dr, Phone: 97235302906, Email: yaakov.maor@sheba.health.gov.il
Summary
The study is aimed to investigate the safety, tolerability and efficacy of a fixed dose
combination therapy of: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (PEG-IFN
alpha-2a) and Ribavirin (RBV) in Chronic Hepatitis C Genotype 1 Infected adult subjects who
failed to respond following a course of PEG-IFN and RBV Therapy.
Clinical Details
Official title: A Phase I/II, Open Clinical Trial to Assess the Safety, Tolerability and Efficacy of a Fixed Dose Combination Therapy of: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN Alpha-2a) and Ribavirin (RBV) in Chronic Hepatitis C Genotype 1 Infected Subjects Who Failed to Respond Following a Course of Peg-IFN and RBV Therapy (SoC).
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from baseline in physical examinationChange from baseline in vital Signs Change from baseline in clinical laboratory parameters Change from baseline in adverse events
Secondary outcome: HCV RNA level
Detailed description:
This is a phase I/II, open clinical trial to assess the safety, tolerability and preliminary
efficacy data of a fixed dose combination therapy of: HCQ, Peg-IFN alpha-2a and RBV in
chronic hepatitis C genotype 1 infected subjects who failed to respond following a course
of Peg-IFN and RBV Therapy (SoC). The study is a single center trial to be conducted at the
Department of Gastroenterology & Hepatology, at Sheba Medical Center, Tel Hashomer, Israel.
Overall, thirty six (36) patients will be recruited. All patients enrolled will have a
documented history of chronic HCV disease and being non-responder on earlier Peg-IFN based
treatment lasting for at least 12 consecutive weeks prior to study enrolment.
The expected duration of patient screening period prior to enrollment into this study is
in-between six weeks (42 days) up to 2 days prior to the study enrollment day at visit 2
(verification of compliance with inclusion/exclusion criteria including clinical laboratory
results). Eligible patients will be enrolled into the study and will be observed twice on
the first week of the study, once a week during the initiation of the treatment period at
weeks 2,3 and week 4, later during the treatment period once a month at weeks 8-48 and at
two follow up visits post treatment to take place at week 60 and 72 (allowing a time window
of ± 5 days for all visits).
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Males and females between 18 and 70 years old.
2. Subjects diagnosed to have positive HCV antibodies using a third generation test.
3. Subject is diagnosed to have detectable HCV RNA by PCR.
4. Liver biopsy or FibroTest showing a METAVIR score ≥F2 and/or ≥A2.
5. Subject diagnosed to have compensated liver disease.
6. Subject is non-responder (null or partial) on prior Peg-IFN and RBV based treatment
lasting for at least 12 consecutive weeks.
7. Treatment not discontinued due to intolerability to Peg-IFN or RBV.
8. Subjects able to comprehend and give informed consent for participation in this
study.
9. Subject is willing to be treated and commit to all visits.
Exclusion Criteria:
1. Anti HCV therapy contraindications.
2. Subject is identified as a relapser on prior Peg-IFN and RBV based treatment.
3. Hypersensitivity to one of the three drugs (HCQ, Peg-IFN, RBV).
4. Patient has Anaemia,neutropenia, thrombocytopenia, elevated bilirubin levels,
elevated ALT and/or AST, or elevated creatinin and INR greater than 1. 5.
5. Concomitant liver disease other than hepatitis C: chronic hepatitis B, alcoholic
liver disease, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1
antitrypsin deficiency.
6. Decompensated cirrhosis (Child Pugh >A).
7. Clinical evidence for hepatocellular carcinoma.
8. Human immunodeficiency virus co-infection.
9. Major uncontrolled psychiatric illness. Minor or situational depressions are allowed.
10. Active elicit drug or alcohol abuse.
11. Serious co-morbid conditions as: heart failure, significant coronary heart disease,
chronic obstructive pulmonary disease, renal insufficiency, poorly controlled
diabetes, autoimmune disorders, and malignant diseases in the previous 5 years.
12. Immunosuppressive treatment including corticosteroids,
13. Untreated or uncontrolled or thyroid disease.
14. Solid transplant organ (renal, heart, or lung).
15. Pregnancy or unwillingness to practice double contraception or abstinence by the
subject of childbearing potential or partner.
16. Subject objects to the study protocol.
17. Concurrent participation in any other clinical study within 30 days prior to
enrollment.
Locations and Contacts
Yaakov Maor, Dr, Phone: 97235302906, Email: yaakov.maor@sheba.health.gov.il Additional Information
Starting date: January 2011
Last updated: January 6, 2011
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