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

Hepatitis C Virus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058173
• Other study ID #: HP7-92
• Secondary ID: HP7-92
• Status: Completed
• Phase: Phase 4
• First received: February 5, 2014
• Last updated: October 18, 2015
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: October 2015
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee and Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus

Intervention

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

• Chloroquine

• placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Health Policy Research Center	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ALT response which is significant decrease in ALT-(biochemical response during Treatment)		july 2014	Yes
Primary	Loss of HCV RNA at end of treatment which is 8 weeks		march 2014	Yes
Secondary	Two log decrease in HCV RNA at the end of treatment		july 2014	Yes