Trial | NCT03481036  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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 Started
Jun 18
2016
Primary Completion
Dec 31
2020
Anticipated
Study Completion
Dec 31
2020
Anticipated
Last Update
Jun 17
2019

Drug Direct Acting Antivirals [sofosbuvir (sovaldi), daclatasvir (daklinza)]

Sofosbuvir and Daclatasvir

  • Other names: DAAs in Non Cirrhotics

Drug DAAs in Cirrhotics Genotype 2/3 [sofosbuvir (sovaldi), daclatasvir (daklinza), ribavirin (virazole)]

Sofosbuvir and Daclatasvir with weight based ribavirin

Drug DAAs in Cirrhotics Genotye 1,4,5,6 [sofosbuvir (sovaldi), ledipasvir (Harvoni), ribavirin (virazole)]

Sofosbuvir and Ledipasvir with weight based ribavirin

Non cirrhotic Active Comparator

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 Active Comparator

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 Active Comparator

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

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.
No Results Posted