DAA Therapy in Pediatric Patients With Chronic Hepatitis C

Chronic Hepatitis c Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03481036
• Other study ID #: IEC/2018/000323
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2019
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Radha K Dhiman, DM
• Phone: 911722756335
• Email: rkpsdhiman[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Direct Acting Antivirals
Sofosbuvir and Daclatasvir
• DAAs in Cirrhotics Genotype 2/3
Sofosbuvir and Daclatasvir with weight based ribavirin
• DAAs in Cirrhotics Genotye 1,4,5,6
Sofosbuvir and Ledipasvir with weight based ribavirin

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research	Chandigarh

Sponsors (2)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research	Directorate of Health and Family Welfare, Punjab

Country where clinical trial is conducted

India, 

Outcome

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