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DAA Therapy in Pediatric Patients With Chronic Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03481036
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
Directorate of Health and Family Welfare, Punjab
Information provided by (Responsible Party):
Radha K Dhiman, Postgraduate Institute of Medical Education and Research

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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis c Drug: Direct Acting Antivirals Drug: DAAs in Cirrhotics Genotype 2/3 Drug: DAAs in Cirrhotics Genotye 1,4,5,6 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 18, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Non cirrhotic
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
Sofosbuvir and Daclatasvir
Other Name: DAAs in Non Cirrhotics

Active Comparator: Genotype 1,4,5 and 6 with cirrhosis
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
Sofosbuvir and Ledipasvir with weight based ribavirin

Active Comparator: Genotype 2 and 3 with Cirrhosis
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
Sofosbuvir and Daclatasvir with weight based ribavirin




Primary Outcome Measures :
  1. Sustained Virological Response (SVR 12) [ Time Frame: 12 weeks after completion of therapy ]
    HCV RNA undetectable by quantitative Real time Polymerase Chain Reaction (PCR)



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481036


Contacts
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Contact: Radha K Dhiman, DM 911722756335 rkpsdhiman@hotmail.com

Locations
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India
Post Graduate Institute of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: Radha K Dhiman, DM    911722756335    rkpsdhiman@hotmail.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Directorate of Health and Family Welfare, Punjab
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radha K Dhiman, Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03481036    
Other Study ID Numbers: IEC/2018/000323
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radha K Dhiman, Postgraduate Institute of Medical Education and Research:
Mukh Mantri Punjab Hepatitis C Relief Fund,MMPHCRF
Direct acting antiviral agents (DAA)
Chronic Hepatitis C
Pediatric population
Adolescent Chronic Hepatitis C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents