NCT03481036

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

4.5 years

First QC Date

March 22, 2018

Last Update Submit

June 13, 2019

Conditions

Chronic Hepatitis c

Keywords

Mukh Mantri Punjab Hepatitis C Relief Fund,MMPHCRFDirect acting antiviral agents (DAA)Chronic Hepatitis CPediatric populationAdolescent Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Sustained Virological Response (SVR 12)

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

    12 weeks after completion of therapy

Study Arms (3)

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

Drug: Direct Acting Antivirals

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

Drug: DAAs in Cirrhotics Genotye 1,4,5,6

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

Drug: DAAs in Cirrhotics Genotype 2/3

Interventions

Direct Acting AntiviralsDRUG

Sofosbuvir and Daclatasvir

Also known as: DAAs in Non Cirrhotics
Non cirrhotic
DAAs in Cirrhotics Genotype 2/3DRUG

Sofosbuvir and Daclatasvir with weight based ribavirin

Genotype 2 and 3 with Cirrhosis
DAAs in Cirrhotics Genotye 1,4,5,6DRUG

Sofosbuvir and Ledipasvir with weight based ribavirin

Genotype 1,4,5 and 6 with cirrhosis

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30211847DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Radha K Dhiman, DM

CONTACT

911722756335rkpsdhiman@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2018

First Posted

March 29, 2018

Study Start

June 18, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 17, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)