Pharmacokinetics, Safety, Efficacy and Acceptability of Daclatasvir Plus Sofosbuvir in HCV-infected Children

NCT ID: NCT05854511

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-05
• Study Completion Date: 2024-04-13

Brief Summary

This is an interventional, single center, single arm clinical trial to assess the pharmacokinetics, safety, efficacy, and acceptability of daclatasvir plus sofosbuvir in treatment-naïve children weighing between 14 and 35 kg with chronic HCV GT 1-6 infection.

Detailed Description

This is an interventional, single center, single arm clinical trial to assess the pharmacokinetics, safety, efficacy, and acceptability of daclatasvir plus sofosbuvir in treatment-naïve, children weighing between 14 and 35 kg with chronic HCV GT 1-6 infection.

All enrolled patients will receive daclatasvir 30 mg orally once daily plus sofosbuvir at a dose of 200 mg (2x 100 mg tablets) orally once daily for 12 weeks.

Patients will be followed closely for disease progression and any hypersensitivity or adverse reactions due to therapy. Laboratory values to be monitored at baseline are serum creatinine, bilirubin, Aspartate transaminase (AST), Alanine transaminase (ALT), viral load (VL).

patients will be recruited in each of two weight bands (14 to < 17 kg and 17 to 35 kg). The study is mainly powered for non-compartmental pharmacokinetics determination of DCV, SOF and GS-331007. Patient recruitment will be done at Ain Shams university hospitals, Egypt. The study be will conducted after approval by the corresponding research ethical committee and obtaining an informed consent from the parents or the legal guardians, and -whenever applicable- an assent from the patients.

Total number of visits is 7 for patients who will complete the study, a screening visits, at the first day of therapy, at weeks 1, 4, 8, 12 and 24 after starting daclatasvir plus sofosbuvir. Patients who will complete their treatment schedule will come after 12 weeks for assessment of SVR. Duration of follow up will be 6 months from treatment initiation in addition to screening period (2-4 weeks).

Conditions

HCV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Daclatasvir Plus Sofosbuvir

treatment-naïve children infected with chronic HCV will be stratified according to weight

1. Children weighing 14 <17 Kg

2. Children weighting 17<35 Kg

Group Type: EXPERIMENTAL

Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tablets

Intervention Type: DRUG

Daclatasvir 30 mg orally once daily plus Sofosbuvir at a dose of 200 mg (2x 100 mg tablets) orally once daily for 12 weeks.

Interventions

Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tablets

Daclatasvir 30 mg orally once daily plus Sofosbuvir at a dose of 200 mg (2x 100 mg tablets) orally once daily for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Daklinza; Sovaldi

Eligibility Criteria

Inclusion Criteria

• Children more than 3 years of age and weighing 14-35kg
• Infected with HCV genotypes 1-6
• Treatment Naïve HCV-infected children
• Signing a written consent form by the parent or the legal guardian, and -whenever applicable- an assent by the patient
• Screening laboratory values within predefined thresholds:

1. Absolute neutrophil count ≥ 1,500/mm3

2. Platelets > 50,000 cells/mm3

3. Albumin > 3.5 mg/dL

4. Prothrombin Time PT < 4 sec above control Or International Normalized Ratio INR <1.7 3

5. Random blood glucose level within normal range (> 70 mg/dL and < 200 mg/dL)

6. Serum creatinine < 1.5 mg/dL

Exclusion Criteria

• Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
• Clinical hepatic decompensation, i.e., Child-Turcotte-Pugh CTP class B or C (i.e., jaundice, ascites, encephalopathy, or variceal hemorrhage)
• Renal dysfunction, i.e., eGFR < 60 mL/min/1.73 m2 or on regular dialysis as calculated by Schwartz Formula
• Alfa-fetoprotein level > 50 ng/mL
• Chronic liver disease due to a cause other than HCV or Known hypersensitivity to daclatasvir or sofosbuvir.
• History of gastrointestinal disease or gastrointestinal surgical procedure that would impair the absorption of the study drug
• Blood/blood product transfusion within 4 weeks prior to study.
• Systemic corticosteroid administration for more than 2 weeks starting from two weeks before study inclusion and till the end of treatment period (pulmonary/nasal administration is permitted).
• Psychiatric hospitalization, suicide attempt or disability resulting from psychiatric illness within the prior 5 years.
• Ongoing treatment with any medications interacting with daclatasvir/sofosbuvir.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Manal Hamdy El-Sayed

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manal H. El-Sayed, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt

Locations

Faculty of Medicine, Ain-Shams University Research Institute-Clinical Research Centre (MASRI-CRC)

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Manal H. El-Sayed, MD

Role: CONTACT

manalhelsayed@yahoo.co.uk

002-01227461120

Facility Contacts

Manal H. El-Sayed, MD

Role: primary

manalhelsayed@yahoo.co.uk

002-01227461120

Other Identifiers

FMASU P04a / 2022

Identifier Type: -

Identifier Source: org_study_id