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Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C]

NCT03480932 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-05-18

Study results available
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Summary

The primary objective of this pilot trial is to compare the efficacy, measured as sustained virologic response (SVR) at least 12 weeks after completion of therapy, across three study regimens/delivery modalities: Arm 1 - 4 weeks of sofosbuvir (SOF) + daclatasvir (DAC) + pegylated interferon alfa-2a (PEG) delivered using directly observed therapy (DOT); Arm 2 - 12 weeks of SOF+DAC delivered using DOT; and Arm 3 - 12 weeks of SOF+DAC delivered as per standard of care (monthly dispensation with no DOT). Secondary objectives are 1)To compare the cost per SVR for each of the three study arms; 2) To compare adherence among persons across the three study arms; 3) To evaluate the safety, tolerability and acceptability of treatment in the three arms.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Sofosbuvir

Direct acting antiviral agent used for the treatment of hepatitis C

DRUG

Daclatasvir

Direct acting antiviral agent used for the treatment of hepatitis C

DRUG

Pegylated Interferon alfa-2a

Antiviral agent used for the treatment of hepatitis C

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • YR Gaitonde Centre for AIDS Research and Education

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Shruti Mehta, PhD, MPH · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-02
Primary Completion
2018-11-02
Completion
2018-11-02

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03480932 on ClinicalTrials.gov