A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection

NCT03186313 | Completed Phase 3

• 1 other identifier: ELH - 2016
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

A phase 3 Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of the combined single dose of Dactavira Plus (EPGCG, Sofosbuvir , Daclatasvir \& Ribavirin) versus Sofosbuvir + Daclatasvir + Ribavirin (Part A) and a single dose of Dactavira (EPGCG, Sofosbuvir \& Daclatasvir) versus Sofosbuvir + Daclatasvir (Part B) in Egyptian Adults with Chronic Genotype 4 HCV Infection.

Conditions

Hepatitis C

Keywords

HCV; Sofosbuvir; Ribavirin

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is SVR12 (ie, HCV RNA < LLOQ 12 weeks post-treatment)

  The primary efficacy endpoint is SVR12 (ie, HCV RNA \< LLOQ 12 weeks post-treatment)

  12 weeks

Study Arms (4)

Part A: Arm 1

EXPERIMENTAL

Single daily dose (2 Tablets) of Dactavira Plus each tablet contains (EPGCG 200 mg , Sofosbuvir 200mg, Daclatasvir 30 mg, Ribavirin 400 mg) for 12 weeks.

Drug: Dactavira Plus

Part A: Arm 2

ACTIVE COMPARATOR

Daily dose including Sofosbuvir 400 mg , Daclatasvir 60 mg \& Ribavirin 800 mg for 12 weeks. Treatment assignments will be stratified according to the presence or absence of cirrhosis.

Drug: Sofosbuvir + Daclatasvir + Ribavirin

Part B: Arm 3

EXPERIMENTAL

Single daily dose (1 Tablet) of Dactavira each tablet contains (EPGCG 400 mg , Sofosbuvir 400mg, Daclatasvir 60 mg) for 12 weeks.

Drug: Dactavira

Part B: Arm 4

ACTIVE COMPARATOR

Daily dose including Sofosbuvir 400 mg \& Daclatasvir 60 mg for 12 weeks.

Drug: Sofosbuvir + Daclatasvir

Interventions

Dactavira Plus DRUG

1 Single daily dose (2 Tablets) of Dactavira Plus each tablet contains (EPGCG 200 mg , Sofosbuvir 200mg, Daclatasvir 30 mg, Ribavirin 400 mg) for 12 weeks.

Part A: Arm 1

Sofosbuvir + Daclatasvir + Ribavirin DRUG

Daily dose including Sofosbuvir 400 mg , Daclatasvir 60 mg \& Ribavirin 800 mg for 12 weeks.

Part A: Arm 2

Dactavira DRUG

Single daily dose (1 Tablet) of Dactavira each tablet contains (EPGCG 400 mg , Sofosbuvir 400mg, Daclatasvir 60 mg) for 12 weeks

Part B: Arm 3

Sofosbuvir + Daclatasvir DRUG

Daily dose Sofosbuvir 400 mg \& Daclatasvir 60 mg for 12 weeks

Part B: Arm 4

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide written informed consent.
• Male or female, age ≥ 18 years.
• HCV RNA ≥ 104 IU/mL at screening.
• Confirmed chronic HCV infection as documented by either:
• a. A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit.
• HCV genotype 4 at screening as determined by the Central Laboratory. Any non definitive results will exclude the subject from study participation.
• a Presence of cirrhosis is defined as any one of the following:
• Liver biopsy within 2 years of Screening showing cirrhosis
• Fibroscan with a result of ≥ 12.5 kPa within 6 months of Baseline/Day1
• Body mass index (BMI) ≥ 18 kg/m2.
• Screening ECG without clinically significant abnormalities.
• Subjects must have the following laboratory parameters at screening:
• ALT ≤ 10 x the upper limit of normal (ULN)
• AST ≤ 10 x ULN
• Hemoglobin ≥ 12 g/dL for male, ≥ 11 g/dL for female subjects

You may not qualify if:

• Prior exposure to IFN, Ribavirin, or other approved or experimental direct-acting antiviral targeting the HCV.
• Current or prior history of any of the following:
• a Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) b Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol, or, current evaluation for a potentially clinically significant illness (other than HCV) c Gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drug d Solid organ transplantation e Significant pulmonary disease, significant cardiac disease or porphyria f Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years Subjects with psychiatric illness (without the prior mentioned conditions) that is well-controlled on a stable treatment regimen for at least 6 months prior to Baseline/Day 1 or that has not required medication in the last 12 months may be enrolled.
• g Any malignancy within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.), or current evaluation for possible malignancy h Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy i 4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
• \. Contraindication to Ribavirin therapy e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).
• \. History of malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for malignancy are not eligible.
• \. Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent \> 10 mg/day).
• \. Clinically-relevant drug or alcohol abuse within 12 months of screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription should be approved by the investigator.
• \. History of solid organ transplantation. 10. Current or prior history of clinical hepatic decompensation (eg, ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome).
• \. History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
• \. History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug.
• \. History of significant pulmonary disease, significant cardiac disease or porphyria.
• \. Excessive alcohol ingestion, defined as 3 glasses/day (1 glass is equivalent to 284 mL beer, 125 mL wine, or 25 mL distilled spirits) for females and 4 glasses/day for males.
• \. Known hypersensitivity to Ribavirin, the study investigational medicinal product, the metabolites, or formulation excipients.
• Prior exposure to IFN, Ribavirin, or other approved or experimental direct-acting antiviral targeting the HCV.

Sponsors & Collaborators

• Egyptian Liver Hospital: lead
• Wadi El Nil Hospital: collaborator

Study Sites (1)

Egyptian Liver Hospital

Sherbin, Dakahlia Governorate, 35681, Egypt

Location

Related Publications (1)

• Doss W, Shiha G, Hassany M, Soliman R, Fouad R, Khairy M, Samir W, Hammad R, Kersey K, Jiang D, Doehle B, Knox SJ, Massetto B, McHutchison JG, Esmat G. Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4. J Hepatol. 2015 Sep;63(3):581-5. doi: 10.1016/j.jhep.2015.04.023. Epub 2015 May 1.

  PMID: 25937436 BACKGROUND

Related Links

• Egyptian Liver Hospital site

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; daclatasvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 14, 2017
• Study Start: September 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: November 30, 2017
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

EG (1)