Clinical trial NCT03481036: DAA Therapy in Pediatric Patients With Chronic Hepatitis C
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis c
Keywords: Mukh Mantri Punjab Hepatitis C Relief Fund,MMPHCRF
Direct acting antiviral agents (DAA)
Chronic Hepatitis C
Pediatric population
Adolescent Chronic Hepatitis C
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
Collaborators: name: Directorate of Health and Family Welfare, Punjab
First posted: 2018-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Sustained Virological Response (SVR 12)
timeFrame: 12 weeks after completion of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
Study officials:
References:
citation: Dhiman RK, Grover GS, Premkumar M, Taneja S, Duseja A, Rathi S, Satsangi S. Direct-acting antiviral Therapy Is Safe and Effective in Pediatric Chronic Hepatitis C: The Public Health Perspective. J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):74-80. doi: 10.1097/MPG.0000000000002139.