- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03481036
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Radha K Dhiman, DM
- Phone Number: 911722756335
- Email: rkpsdhiman@hotmail.com
Study Locations
-
-
-
Chandigarh, India, 160012
- Recruiting
- Post Graduate Institute of Medical Education and Research
-
Contact:
- Radha K Dhiman, DM
- Phone Number: 911722756335
- Email: rkpsdhiman@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
Sofosbuvir and Daclatasvir
Other Names:
|
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
|
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
|
Sofosbuvir and Daclatasvir with weight based ribavirin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained Virological Response (SVR 12)
Time Frame: 12 weeks after completion of therapy
|
HCV RNA undetectable by quantitative Real time Polymerase Chain Reaction (PCR)
|
12 weeks after completion of therapy
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Anti-Infective Agents
- Antiviral Agents
Other Study ID Numbers
- IEC/2018/000323
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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