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Hepatitis C, ChronicPhase 2C-DOTNCT02541409

Directly Observed Therapy for HCV in Chennai, India

A Phase 2 study testing Sofosbuvir, Pegylated Interferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Johns Hopkins Bloomberg School of Public Health at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this pilot trial is to evaluate the feasibility of 12 weeks vs. 24 weeks of field-based directly observed therapy (DOT) for HCV therapy in a resource-limited setting. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Sofosbuvir, Pegylated Interferon alfa-2a and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIndia
Study dates
Sep 2015to Dec 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing/able to provide consent
  • Age ≥ 18
  • Chronic HCV (HCV RNA positive)
  • Resident of Chennai and can provide locator information
  • If co-infected with HIV, must have CD4 (Cluster of Differentation 4) > 350 cells/mm3 and either: 1) ART naïve or 2) if on ART be on a tenofovir-containing regimen. If a participant's CD4 drops below 350 cells/μl (threshold for treatment in India), will have to initiate a tenofovir-containing regimen (current standard of care).
  • Participants must have the following at screening:
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  • Alanine Aminotransferase (ALT) ≤ 10 x the upper limit of normal (ULN)
  • Aspartate Aminotransferase (AST) ≤ 10 x ULN
  • Hemoglobin ≥ 12 g/dl for males and 11 g/dl for females
  • International normalized ratio (INR) ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
  • Albumin ≥ 3 g/dl
  • Direct bilirubin ≤ 1.5 x ULN
  • Creatinine clearance ≥ 60 ml/min (Cockgroft-Gault Equation)
  • Alpha fetoprotein < 50 ng/ml
  • Absolute neutrophil count (ANC) ≥ 1,500/μL
  • Platelets ≥ 90,000/μL
  • Thyroid stimulating hormone (TSH) ≤ ULN
  • A female subject is eligible if it is confirmed that she is:
  • Not pregnant or nursing
  • Of non-childbearing potential (i.e., women who have had hysterectomy, have both ovaries removed or medically documented ovarian failure, or are postmenopausal women > 50 years of age with cessation (for ≥12 months) of previously occurring menses
  • Of childbearing potential and negative urine pregnancy test prior to randomization and agree to one of the following from 3 weeks prior to Baseline/Day 1 until 6 months after the last dose of RBV.
  • Complete abstinence from intercourse.
  • Or
  • Consistent use of approved methods of birth control in addition to a male partner who correctly uses a condom from 3 weeks prior to Baseline/Day 1 until 6 months after the last dose of RBV.
  • Male participants must agree to consistently and correctly use a condom. If their female partner is of childbearing potential, their partner must agree to use one of the study approved non-hormonal methods of birth control or a hormone-containing contraceptive, from the date of screening until 7 months after their last dose of RBV
  • Male participants must agree to refrain from sperm donation for at least 7 months after the last dose of RBV.
  • Of generally good health as determined by the investigator.
  • Able to comply with the dosing instructions for study drug administration and willing to complete the study schedule of assessments.

Who cannot join

  • Pregnant/nursing female or male with pregnant/nursing female partner.
  • Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage, MELD<12)
  • Prior hepatitis C treatment
  • Infection with hepatitis B virus
  • Chronic use of systematically administered immunosuppressive agents (e.g., prednisone equivalent >10 mg/day)
  • Use of any prohibited concomitant medications within 28 days of the Baseline/Day 1 visit.
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  • Contraindications to RBV therapy or PEG/RBV
  • Known hypersensitivity to RBV or PEG, the metabolites or formulation excipients
  • Additional exclusion criteria related to Aim 1 regimen
  • Pre-existing significant psychiatric condition(s) including severe depression, severe bipolar disorder and schizophrenia. Other psychiatric disorders are permitted if the condition is well controlled with a stable treatment regimen for ≥ 1 year from screening.
  • Presence of autoimmune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis).
  • History of clinical significant retinal disease.

Trial locations and contacts

1 site in 1 country.

India1 site

  • YR Gaitonde Centre for AIDS Research and Education

    Chennai, Tamil Nadu, 600113

Other trials in India

About this study

Official title: Directly Observed Therapy for the Delivery of HCV Therapy Among HCV-infected Individuals in Chennai, India

The primary objective of this pilot trial is to evaluate the feasibility of 12 weeks vs. 24 weeks of field-based directly observed therapy (DOT) for HCV therapy in a resource-limited setting. The investigators will compare treatment completion rates among 50 persons chronically infected with HCV who will be randomized to receive either 1) 12 weeks of sofosbuvir (SOF) + ribavirin (RBV) + pegylated interferon alfa-2a (PEG); or 2) 24 weeks of SOF + RBV. Treatment will be delivered daily by field workers at a location of a participants choosing. Secondary objectives are 1) To compare the efficacy of SOF+RBV with or without PEG as measured by the proportion of subjects with sustained viral response at 12 weeks after discontinuation of therapy (SVR12); 2) To evaluate the safety and tolerability of SOF+RBV with or without PEG; 3) To assess the impact of SVR12 on insulin resistance.

Read the detailed description

This will be a non-blinded randomized clinical trial with 50 participants randomized at a 1:1 allocation ratio to one of two treatment arms.

Arm 1: Sofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks

Arm 2: Sofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks

Pegylated-interferon alfa-2a (PEG) will be delivered subcutaneously once weekly. Sofosbuvir (SOF) and ribavirin (RBV) will be taken orally once daily for the entire study period.

The study will take place at the YR Gaitonde Centre for AIDS Research and Education (YRGCARE). YRG CARE is a non-profit medical and research institution in Chennai. YRGCARE Medical Centre provides medical care for more than 18,000 persons with HIV disease. Currently more than 8000 persons are receiving highly active antiretroviral therapy at the center.

Participants will be recruited from the YR Gaitonde Centre for Substance Abuse Research (YRGCSAR), which is affiliated with YRGCARE. The investigators will primarily recruit subjects from a cohort study of current and former people who inject drugs (PWID) that is ongoing at the same center. Eligible participants will be randomized to one of the two treatment arms after providing written informed consent. Treatment will be delivered directly to participants daily by field workers at a location of the participants choosing. Participants will be asked to visit the study clinic every four weeks during treatment and 12 weeks after completing treatment for additional study procedures. In addition, participants in Arm 1 will be asked to visit the clinic every week to receive their PEG injection.

The primary outcome is treatment completion. Secondary outcomes include SVR12, safety and tolerability and insulin resistance.

Being tested
Sofosbuvir, Pegylated Interferon alfa-2a, Ribavirin
Keywords
directly observed therapy, sofosbuvir, ribavirin, pegylated interferon, resource-limited setting
Medical subject headings
Hepatitis C, Chronic, Directly Observed Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SofosbuvirDrug

    Also called Sovaldi, Hepcvir, MyHep, Hepcinat, Resof, SoviHep

    Direct acting antiviral agent used for the treatment of hepatitis C

  • Pegylated Interferon alfa-2aDrug

    Also called Pegasys, Taspiance

    Antiviral agent used for the treatment of hepatitis C

  • RibavirinDrug

    Also called Rebetol, Copegus, Univirin

    Antiviral agent (guanosine analogue) used for the treatment of hepatitis C

Study groups in NCT02541409
Study groupRoleWhat they receive
SOF+PEG+RBVActive comparatorSofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks
Receives: Drug: Sofosbuvir; Drug: Pegylated Interferon alfa-2a; Drug: Ribavirin
SOF+RBVActive comparatorSofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks
Receives: Drug: Sofosbuvir; Drug: Ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HCV Treatment Completion

    The percentage of subjects that complete their course of treatment

    Measured: 12 weeks from baseline for SOF+PEG+RBV and 24 weeks from baselne for SOF+RBV

Secondary outcomes (3)

  1. Sustained Virologic Response (SVR)

    The percentage of participants who achieve SVR as assessed by undetectable HCV RNA measured 12 weeks after treatment completion

    Measured: 24 weeks from baseline for SOF+PEG+RBV and 36 weeks from baseline for SOF+RBV

  2. Serious Adverse Events

    Number of participants with treatment-related serious adverse events by laboratory tests and physician examination

    Measured: 24 weeks from baseline SOF+PEG+RBV and 36 weeks from baseline for SOF+RBV

  3. Change in Insulin Resistance

    Change in insulin resistance while on treatment by the homeostasis model assessment - insulin resistance (HOMA-IR). HOMA-IR is calculated according to the formula (fasting insulin (microU/L)+fasting glucose (nmol/L)/22.5. Fasting insulin and glucose measurements are obtained using whole blood.

    Measured: Difference from entry to 24 weeks for SOF+PEG+RBV and difference from entry to 36 weeks for SOF+RBV

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02541409
Sponsor's protocol ID
R01DA02672
Other IDs
R01DA026727
Acronym
C-DOT
Status last verified
Mar 2021
First submitted
31 Aug 2015
Last updated
15 Apr 2021
Data monitoring committee
No

Publications

  • Solomon SS, Sulkowski MS, Amrose P, Srikrishnan AK, McFall AM, Ramasamy B, Kumar MS, Anand S, Thomas DL, Mehta SH. Directly observed therapy of sofosbuvir/ribavirin +/- peginterferon with minimal monitoring for the treatment of chronic hepatitis C in people with a history of drug use in Chennai, India (C-DOT). J Viral Hepat. 2018 Jan;25(1):37-46. doi: 10.1111/jvh.12761. Epub 2017 Aug 14.

    PubMed 28719029

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sofosbuvir, Pegylated Interferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Johns Hopkins Bloomberg School of Public Health at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HCV Treatment Completion (time frame: 12 weeks from baseline for SOF+PEG+RBV and 24 weeks from baselne for SOF+RBV). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02541409, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.

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