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Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy

A Randomized, Placebo-Controlled Triple-Blind Trial to Evaluate the Clinical Efficacy of Chloroquine in the Treatment of HCV Patients Resistant to Standard Therapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013121515805N1
Enrollment
20
Registered
2014-04-11
Start date
2014-03-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non- Response HCV Patients. Chronic viral hepatitis C

Interventions

Intervention 1: Intervention Group:Chloroquine,One Tablet(150mg)/day for 8 weeks. Paients Wll be Followed at Baseline, 4, 8 and 12 Weeks after Starting Intervention for 2 log Decrease at HCV RNA Load
Treatment - Drugs
Intervention Group:Chloroquine,One Tablet(150mg)/day for 8 weeks. Paients Wll be Followed at Baseline, 4, 8 and 12 Weeks after Starting Intervention for 2 log Decrease at HCV RNA Load.
Placebo Group: One Placebo Tablet/Day for 8 Weeks. Paients Will be Followed at Baseline, 4, 8 and 12 Weeks after Starting Intervention for 2 log Decrease at HCV RNA Load.

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria:18-60 Age; Non-Responders HCV Patients; Informed Consent Exclusion Criteria: Chloroquine Sensitivity; Presence of Decompensate Cirrhosis; Receiving Anti Neoplasm; Anti Viral or Immunomedulator Drugs During 6 Months Prior to Study; Coinfection with Hepatitis A,B, C,D Viruses or HIV; Pregnancy and Breast Feeding; Active Alcohol User( Recent 2 Year).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Change of HCV RNA at end of treatment. Timepoint: 8 weeks after start treatment. Method of measurement: Q-PCR.;Change of HCV RNA at End of Intervention. Timepoint: 12 weeks after start treatment. Method of measurement: Q-PCR.

Secondary

MeasureTime frame
Two log Decrease in Hepatitis C Virus RNA. Timepoint: End of Follow Up(12 weeks after staring intervention). Method of measurement: Q-PCR.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPayam Peymani

Health Policy Research Center

peymanip@sums.ac.ir+98 71 1230 9615

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026