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

NCT05854511 | Unknown Phase 3 DMC

• 1 other identifier: FMASU P04a / 2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

HCV

Keywords

Daclatasvir; Sofosbuvir; Children; HCV; Pharmacokinetics; Safety; Efficacy; Acceptability

Outcome Measures

Primary Outcomes (2)

• Plasma concentration of Daclatasvir

  The plasma concentration of Daclatasvir on day 8 will be used to derive the Pharmacokinetic parameters using the Non-Compartmental analysis (NCA)

  one week

• Plasma concentration of Sofosbuvir

  The plasma concentration of Daclatasvir on day 8 will be used to derive the Pharmacokinetic parameters using the Non-Compartmental analysis (NCA)

  one week

Secondary Outcomes (2)

• Efficacy of Daclatasvir 30 MG oral tablets and Sofosbuvir 200 MG oral tablets once daily for 12 weeks

  24 weeks

• Safety of Daclatasvir 30 MG oral tablets and Sofosbuvir 200 MG oral tablets once daily for 12 weeks

  24 weeks

Study Arms (1)

Daclatasvir Plus Sofosbuvir

EXPERIMENTAL

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

Drug: Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tablets

Interventions

Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tablets 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.

Also known as: Daklinza, Sovaldi

Daclatasvir Plus Sofosbuvir

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Absolute neutrophil count ≥ 1,500/mm3
• Platelets \> 50,000 cells/mm3
• Albumin \> 3.5 mg/dL
• Prothrombin Time PT \< 4 sec above control Or International Normalized Ratio INR \<1.7 3
• Random blood glucose level within normal range (\> 70 mg/dL and \< 200 mg/dL)
• Serum creatinine \< 1.5 mg/dL

You may not qualify if:

• 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.
• Psychiatric hospitalization, suicide attempt or disability resulting from psychiatric illness within the prior 5 years.
• Ongoing treatment with any medications interacting with daclatasvir/sofosbuvir.

Sponsors & Collaborators

• Ain Shams University: lead
• Cairo University: collaborator

Study Sites (1)

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

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Interventions

Sofosbuvir; Tablets; daclatasvir

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Manal H. El-Sayed, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manal H. El-Sayed, MD

CONTACT

002-01227461120; manalhelsayed@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: May 11, 2023
• Study Start: June 5, 2022
• Primary Completion: December 31, 2023
• Study Completion: April 13, 2024
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

EG (1)