DAA Therapy in Pediatric Patients With Chronic Hepatitis C

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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 services and safety of 12- or 24-weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) with or without ribavirin (RBV) in the treatment of pediatric chronic hepatitis C will be assessed

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Collaborator: Directorate of Health and Family Welfare, Punjab
• Treatments: Antiviral Agents; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.