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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03481036

Enrollment

100

Registered

2018-03-29

Start date

2016-06-18

Completion date

2020-12-31

Last updated

2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGDirect Acting Antivirals

Sofosbuvir and Daclatasvir

DRUGDAAs in Cirrhotics Genotype 2/3

Sofosbuvir and Daclatasvir with weight based ribavirin

DRUGDAAs in Cirrhotics Genotye 1,4,5,6

Sofosbuvir and Ledipasvir with weight based ribavirin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

India

Contacts

Primary ContactRadha K Dhiman, DM

rkpsdhiman@hotmail.com911722756335

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026