AzTrials
AzTrials

Hepatitis C, ChronicPhase 2/3NCT03480932

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

A Phase 2/3 study testing Sofosbuvir, Daclatasvir and Pegylated Interferon alfa-2a 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
Search all trials

Trial 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… 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, Daclatasvir and Pegylated Interferon alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteIndia
Study dates
2 Feb 2018to 2 Nov 2018
Phase
Phase 2/3
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 and able to provide written informed consent
  • Age ≥ 18 years
  • Documented evidence of chronic HCV infection (HCV RNA positive)
  • Participant is a resident of Bilaspur and can provide locator information that can be verified by one of the study staff
  • If participant is co-infected with HIV, he/she must have a cluster of differentiation 4 (CD4) > 350 cells/mm3 and be either: 1) antiretroviral therapy (ART) naïve or 2) on ART be on a tenofovir-containing regimen. If a subject's CD4 drops below 350 cells/μl (current threshold for HIV treatment in India), he/she will be able to initiate ART but we will ensure that the subject starts on a tenofovir-containing regimen, which is currently the standard for persons newly initiating ART in India.
  • Subjects must have the following laboratory parameters at screening:
Show all 31Show fewer
  • alanine aminotransferase (ALT) ≤ 10 x the upper limit of normal (ULN)
  • aspartate aminotransferase (AST) ≤ 10 x ULN
  • Hemoglobin ≥ 10 g/dl for male and 9 g/dl for female subjects
  • 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 ≥ 30 ml/min as calculated by the Cockcroft-Gault Equation
  • Alpha fetoprotein < 50 ng/ml
  • Absolute neutrophil count (ANC) ≥ 1,500/μL
  • Platelets ≥ 90,000/μL
  • Thyroid stimulating hormone (TSH) ≤ ULN
  • FIB-4 <3.25. FIB-4 is a non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4) which is calculated as the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: FIB-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A FIB-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis.) Participants with a FIB-4 >3.25 will be referred to the medical gastroenterology department for further assessment for cirrhosis. If cirrhosis is ruled out by medical gastroenterology, participants can be rescreened for the study.
  • A female subject is eligible to enroll in the study if it is confirmed that she is:
  • Not pregnant or nursing
  • Not of childbearing potential (i.e., women who have had a 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 (i.e., women who have not had a hysterectomy, both ovaries removed or medically documented ovarian failure). [NOTE: Women ≤50 years of age with amenorrhea will be considered to be of childbearing potential.] These women must have a negative urine pregnancy test at screening and a negative urine pregnancy test on the Baseline /Day 1 visit prior to randomization and agree to one of the following modes of contraception for the duration of treatment and 12 weeks thereafter.
  • Complete abstinence from intercourse. Periodic abstinence (e.g., calendar, ovulation, sumptothermal, post-ovulation methods) is NOT permitted.
  • or
  • Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from 3 weeks prior to Baseline/Day 1 until the end of treatment. Women of childbearing potential must not rely on hormone-containing contraceptives as a form of birth control during the study. Female subjects using a hormone containing contraceptive prior to screening may continue their contraceptive regimen in addition to the study specified methods of birth control.
  • intrauterine device (IUD) with a documented failure rate of less than 1% per year
  • female barrier method: cervical cap or diaphragm with spermicidal agent
  • tubal sterilization
  • vasectomy in male partner
  • Subjects must be of generally good health as determined by the investigator.
  • Subjects must be able to comply with the dosing instructions for study drug administration and be willing to complete the study schedule of assessments.

Who cannot join

  • Pregnant or nursing female
  • Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage, model for end-stage liver disease (MELD)<12)
  • Prior treatment for hepatitis C virus infection
  • Infection with hepatitis B virus (HBsAg positive)
  • 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.
Show all 12Show fewer
  • Contraindications to PEG
  • Known hypersensitivity to the metabolites or formulation excipients of PEG (for Arm 1 subjects)
  • Active 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, or inactive for ≥ 1 year from screening.
  • Presence of autoimmune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, psoriasis of greater than mild severity)
  • History of clinical significant retinal disease
  • Clinical evidence of cirrhosis

Trial locations and contacts

1 site in 1 country.

India1 site

  • YR Gaitonde Centre for AIDS Education and Johns Hopkins University Collaborative Integrated Care Center (YRG-JHU ICC)

    Bilāspur, Chhattisgarh, 495009

Other trials in India

About this study

Official title: Role of Pegylated Interferon in Combination With Direct Acting Antivirals (DAAs) to Cure Hepatitis C As Soon As Possible (ASAP) - Hepatitis C [ASAP-C]

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.

Read the detailed description

This will be a non-blinded randomized clinical trial with 150 participants randomized at a 1:1:1 allocation ratio to one of three treatment arms.

Arm 1: Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach

Arm 2: Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach

Arm 3: Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)

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

The study will take place at the YR Gaitonde Centre for AIDS Education (YRG) and Johns Hopkins University (JHU) Collaborative Integrated Care Center (YRG-JHU ICC) located within the premises of the Chattisgarh Institute of Medical Sciences (CIMS) in Bilaspur in the state of Chattisgarh, India.

Participants will be recruited from the YRG-JHU ICC in Bilaspur, which currently has 514 registered HCV antibody positive clients. The Bilaspur ICC is in the Chattisgarh Institute for Medical Sciences (CIMS).

The primary outcome will be sustained virologic response (SVR12). Secondary outcomes include cost per SVR12, adherence, safety and tolerability.

Being tested
Sofosbuvir, Daclatasvir, Pegylated Interferon alfa-2a
Keywords
directly observed therapy, sofosbuvir, daclatasvir, 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

    Direct acting antiviral agent used for the treatment of hepatitis C

  • DaclatasvirDrug

    Also called Daklinza, Natdac, Daclahep, Dacihep

    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

Study groups in NCT03480932
Study groupRoleWhat they receive
SOF+DAC+PEGActive comparatorSofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach
Receives: Drug: Sofosbuvir; Drug: Daclatasvir; Drug: Pegylated Interferon alfa-2a
SOF+DAC, DOTActive comparatorSofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach
Receives: Drug: Sofosbuvir; Drug: Daclatasvir
SOF+DAC, standardActive comparatorSofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)
Receives: Drug: Sofosbuvir; Drug: Daclatasvir

What is being measured

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

  1. SVR12

    Percentage of participants achieving sustained virologic response 12 weeks quantification) after treatment is completed (SVR12) as assessed by HCV RNA less than the lower limit of quantification measured 12 weeks after treatment completion

    Measured: 12 weeks after treatment completion, 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC

Secondary outcomes (2)

  1. Serious Adverse Events

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

    Measured: 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC

  2. Medication Adherence

    Adherence to medication regimen defined using a combination of the biometric data for Arms 1 and 2 and self-report and pill counts for Arm 3. Percentage reporting at least 90% adherence

    Measured: 4 weeks for SOF+DAC+PEG and 12 weeks for SOF+DAC

Timeline

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

  1. First posted29 Mar 2018
  2. Study start2 Feb 2018
  3. Primary completion2 Nov 2018
  4. Study completion2 Nov 2018

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03480932
Sponsor's protocol ID
R01DA026727
Other IDs
R01DA026727
Status last verified
Apr 2021
First submitted
29 Jan 2018
Last updated
18 May 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Sofosbuvir, Daclatasvir and Pegylated Interferon alfa-2a 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 31 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 18 May 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 May 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?

SVR12 (time frame: 12 weeks after treatment completion, 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC). 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 NCT03480932.

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 18 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in