DAA Therapy in Pediatric Patients With Chronic Hepatitis C

Post Graduate Institute of Medical Education and Research, Chandigarh100 enrolled

Overview

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

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-cirrhotic or TN patients and are treated with SOF+DCV for 12-weeks, while genotyping is recommended for patients with cirrhosis and TE patients. Patients with liver cirrhosis or TE and genotype (GT)-3 are being treated with SOF+DCV for 24 weeks, while non-GT-3 patients are being treated with SOF+LDV for 24-weeks. Patients \< 35 kg are being given half doses of medications and patients ≥35 kg are being given adult dosages of SOF (400 mg), LDV (90 mg) and DCV (60 mg) per day.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Chronic Hepatitis c

Interventions

Direct Acting AntiviralsDRUG

Sofosbuvir and Daclatasvir

DAAs in Cirrhotics Genotype 2/3DRUG

Sofosbuvir and Daclatasvir with weight based ribavirin

DAAs in Cirrhotics Genotye 1,4,5,6DRUG

Sofosbuvir and Ledipasvir with weight based ribavirin

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, India

RECRUITING

Outcomes

Primary Outcomes

Sustained Virological Response (SVR 12)

HCV RNA undetectable by quantitative Real time Polymerase Chain Reaction (PCR)

Time frame: 12 weeks after completion of therapy

Central Contacts

Radha K Dhiman, DM

CONTACT

911722756335 rkpsdhiman@hotmail.com

Data from ClinicalTrials.gov

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