DAA Therapy in Pediatric Patients With Chronic Hepatitis C

Not Applicable

• Conditions: Chronic Hepatitis c
• Interventions: Drug: Direct Acting Antivirals; Drug: DAAs in Cirrhotics Genotye 1,4,5,6; Drug: DAAs in Cirrhotics Genotype 2/3

• Registration Number: NCT03481036
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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 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

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-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 Timeline

• Study Start: 2016-06-18
• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-29
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-13
• Last Update Posted: 2019-06-17
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non cirrhotic	Direct Acting Antivirals	Sofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks Patients \< 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg), LDV (90 mg) and DCV (60 mg) per day
Genotype 1,4,5 and 6 with cirrhosis	DAAs in Cirrhotics Genotye 1,4,5,6	Sofosbuvir (SOF)+ Ledipasvir (LDV) for 12-weeks + weight based Ribavirin Patients \< 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg) and LDV (90 mg) per day
Genotype 2 and 3 with Cirrhosis	DAAs in Cirrhotics Genotype 2/3	Sofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks+ weight based Ribavirin Patients \< 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg) and DCV (60 mg) per day

Primary Outcome Measures

Name	Time	Method
Sustained Virological Response (SVR 12)	12 weeks after completion of therapy	HCV RNA undetectable by quantitative Real time Polymerase Chain Reaction (PCR)

Trial Locations

Locations (1)

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India