"Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Hepatitis C Virus

Treatments: Drug: placebo; Drug: Chloroquine; Drug: 150 mg/daily chloroquine compare to placebo for 12 week

Study type: Interventional

Funder types: Other

Identifiers

NCT02058173

HP7-92 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of Chloroquine comparing with placebo for treatment of non- response HCV patients.. In this triple blind pilot study, 20 patients with confirmed chronic hepatitis C will be randomize into treatment group (Chloroquine 150 mg daily, for 8 weeks) or control group (placebo once daily, for 8 weeks). Patients who have receiving anti neoplastic, anti viral or Immunomedullator drugs during 6 months prior to study, have co-infection Hepatitis A,C,D or HIV, severe liver or renal dysfunction, are pregnant or breast fed, or refuse to sign informed consent will be excluded.. At the end of therapy (12 weeks) and at baseline, first, second and third month after receiving drug and placebo HCV Virus load, CBC LFT and biochemical parameters will be evaluated and compared between groups.

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who failed to achieve a decline of 2 log HCV RNA IU/ml after 12 weeks of treatment
• who never achieved undetectable HCV RNA during treatment of a minimum duration of 24 weeks

Exclusion criteria

• Receiving anti neoplasm, anti viral or immunomedulator drugs during 6 months prior to study
• coinfection with Hepatitis A,C,D viruses or HIV
• Severe dysfunction of liver and kidney
• pregnancy
• breast feeding
• refusing to give informed consent
• active Alcohol user
• presence of decompensate cirrhosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

10 participants in 2 patient groups

chloroquine

Experimental group

Description:

150 mg chloroquine and lacebo , one tablet daily for 2 month

Treatment:

Drug: Chloroquine

Drug: 150 mg/daily chloroquine compare to placebo for 12 week

placebo

Experimental group

Description:

150 mg chloroquine and lacebo , one tablet daily for 2 month

Treatment:

Drug: placebo

Drug: 150 mg/daily chloroquine compare to placebo for 12 week