NCT03481036

DAA Therapy in Pediatric Patients With Chronic Hepatitis C

Direct Acting Antiviral Agent (DAA) Therapy Is Safe and Efficacious in Pediatric Patients With Chronic Hepatitis C: Real World Data From the Public Health Perspective

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis c

Interventions

Type	Name	Description
DRUG	Direct Acting Antivirals	Sofosbuvir and Daclatasvir
DRUG	DAAs in Cirrhotics Genotype 2/3	Sofosbuvir and Daclatasvir with weight based ribavirin
DRUG	DAAs in Cirrhotics Genotye 1,4,5,6	Sofosbuvir and Ledipasvir with weight based ribavirin

Timeline

• Start date: 2016-06-18
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-03-29
• Last updated: 2019-06-17

Locations

1 site across 1 country: India