DAA Therapy in Pediatric Patients With Chronic Hepatitis C
NCT ID: NCT03481036
Last Updated: 2019-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-06-18
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Direct Acting Antivirals
Sofosbuvir and Daclatasvir
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
DAAs in Cirrhotics Genotye 1,4,5,6
Sofosbuvir and Ledipasvir with weight based ribavirin
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
DAAs in Cirrhotics Genotype 2/3
Sofosbuvir and Daclatasvir with weight based ribavirin
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages eligible for study: ≥12 to \<18 years (Child)
* Gender eligible for study: either
* Treatment-naive or treatment-experienced: either
Exclusion Criteria
* 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.
12 Years
18 Years
ALL
No
Sponsors
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Directorate of Health and Family Welfare, Punjab
OTHER
Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
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Radha K Dhiman
Professor
Locations
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Post Graduate Institute of Medical Education and Research
Chandigarh, , India
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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IEC/2018/000323
Identifier Type: -
Identifier Source: org_study_id
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