Status:

UNKNOWN

DAA Therapy in Pediatric Patients With Chronic Hepatitis C

Lead Sponsor:

Post Graduate Institute of Medical Education and Research, Chandigarh

Collaborating Sponsors:

Directorate of Health and Family Welfare, Punjab

Conditions:

Chronic Hepatitis c

Eligibility:

All Genders

12-18 years

Phase:

NA

Brief Summary

The Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) is a public health initiative for prevention and control of hepatitis C in the Punjab state, India. The efficacy of decentralised public health...

Detailed Description

Consecutive chronic hepatitis C (HCV) infected children \[age: ≥12 to \<18 years; both treatment-naïve (TN) and treatment-experienced, (TE)\] are being enrolled. Genotyping is not recommended for non...

Eligibility Criteria

Inclusion

  • Chronic hepatitis C, all genotypes
  • Ages eligible for study: ≥12 to \<18 years (Child)
  • Gender eligible for study: either
  • Treatment-naive or treatment-experienced: either

Exclusion

  • Chronic liver disease of a non-HCV etiology
  • serum creatinine \>1.5 mg/dL
  • Evidence of hepatocellular carcinoma or other malignancy
  • Co-infection with hepatitis B virus, or HIV
  • Significant cardiovascular, pulmonary, or neurological disease
  • Evidence of a malabsorption syndrome that could interfere with absorption of orally administered medications
  • History of solid organ or bone marrow transplantation.

Key Trial Info

Start Date :

June 18 2016

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2020

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT03481036

Start Date

June 18 2016

End Date

December 31 2020

Last Update

June 17 2019

Active Locations (1)

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1

Post Graduate Institute of Medical Education and Research

Chandigarh, India, 160012