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DAA Therapy in Pediatric Patients With Chronic Hepatitis C

Primary Purpose

Chronic Hepatitis c

Status

Unknown status

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Direct Acting Antivirals

DAAs in Cirrhotics Genotype 2/3

DAAs in Cirrhotics Genotye 1,4,5,6

About this trial

This is an interventional treatment trial for Chronic Hepatitis c focused on measuring Mukh Mantri Punjab Hepatitis C Relief Fund,MMPHCRF, Direct acting antiviral agents (DAA), Chronic Hepatitis C, Pediatric population, Adolescent Chronic Hepatitis C

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Post Graduate Institute of Medical Education and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Non cirrhotic

Genotype 1,4,5 and 6 with cirrhosis

Genotype 2 and 3 with Cirrhosis

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Sustained Virological Response (SVR 12)

HCV RNA undetectable by quantitative Real time Polymerase Chain Reaction (PCR)

Secondary Outcome Measures

Full Information

NCT ID

NCT03481036

First Posted

March 22, 2018

Last Updated

June 13, 2019

Sponsor

Postgraduate Institute of Medical Education and Research

Collaborators

Directorate of Health and Family Welfare, Punjab

1. Study Identification

Unique Protocol Identification Number

NCT03481036

Brief Title

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

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 18, 2016 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Postgraduate Institute of Medical Education and Research

Collaborators

Directorate of Health and Family Welfare, Punjab

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Non cirrhotic

Arm Type

Active Comparator

Arm Description

Arm Title

Genotype 1,4,5 and 6 with cirrhosis

Arm Type

Active Comparator

Arm Description

Arm Title

Genotype 2 and 3 with Cirrhosis

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Direct Acting Antivirals

Other Intervention Name(s)

DAAs in Non Cirrhotics

Intervention Description

Sofosbuvir and Daclatasvir

Intervention Type

Drug

Intervention Name(s)

DAAs in Cirrhotics Genotype 2/3

Intervention Description

Sofosbuvir and Daclatasvir with weight based ribavirin

Intervention Type

Drug

Intervention Name(s)

DAAs in Cirrhotics Genotye 1,4,5,6

Intervention Description

Sofosbuvir and Ledipasvir with weight based ribavirin

Primary Outcome Measure Information:

Title

Sustained Virological Response (SVR 12)

Description

HCV RNA undetectable by quantitative Real time Polymerase Chain Reaction (PCR)

Time Frame

12 weeks after completion of therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Radha K Dhiman, DM

Phone

911722756335

rkpsdhiman@hotmail.com

Facility Information:

Facility Name

Post Graduate Institute of Medical Education and Research

City

Chandigarh

ZIP/Postal Code

160012

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Radha K Dhiman, DM

Phone

911722756335

rkpsdhiman@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30211847

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.

Results Reference

derived

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DAA Therapy in Pediatric Patients With Chronic Hepatitis C

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