Skip to main content
OpenTrials
Completed

NCT Number: NCT04387526

Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4

This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks.

SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was given as oral tablets in the morning and in the evening based on patient's weight and tolerability (starting dose 600 mg/day to reach 1200 mg/day.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-cirrhotic treatment-naïve participants
  • FIB-4 < 3.25
  • albumin > 3.5
  • total bilirubin < 1.2 mg/dl
  • international normalized ratio (INR) < 1.2
  • platelet count > 150,000 mm3.
  • experienced participants who had previously failed treatment with peg-IFN-α-/RBV, SOF/peg-IFN-α +RBV, or SOF/SMV
  • Naïve cirrhotic participants were confirmed by ultrasonographic features of cirrhosis

Exclusion criteria

  • liver disease of non-HCV etiology
  • hepatitis B or human immune-deficiency virus (HIV) infection
  • poorly controlled diabetic (HbA1C > 9) participants
  • hepatocellular carcinoma
  • a history of extra-hepatic malignancy within 5 years prior to the study
  • pregnant or breast feeding
  • renal disease; serum creatinine > 2.5 mg/dl or eGFR < 30 ml/min
  • evidence of hepatic decompensation; INR > 1.7, serum albumin < 2.8 g/dl, total bilirubin > 3 mg/dl
  • blood picture abnormalities such as anemia (hemoglobin concentration of 10 g/dl or less) and thrombocytopenia (platelet count < 50,000 cells/mm3)
  • major severe illnesses such as congestive heart failure and respiratory failure.

Treatment and study plan

(SOF and DCV)

Drug

Other names: Daklinza is a trade name of daclatasvir, Sovaldi is a trade name of sofosbuvir

(SOF, DCV, and RBV)

Drug

Other names: Daklinza is a trade name of daclatasvir, Sovaldi is a trade name of sofosbuvir

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12

    Time frame: 12 weeks after last dose

    SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/m 12 weeks after the last dose of drugs.

  2. Number of Participants With Adverse Events in Each Treatment Arm

    Time frame: up for 12 weeks after planned End of Treatment (EOT).

    An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs

    Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity

Secondary outcomes

  1. Percentage of Participants With Viral relapse

    Time frame: 12 weeks after last dose

    Viral relapse was HCV RNA level ≤ 15 IU/ml at EOT, but detectable HCV RNA level > 15 IU/ml 12 weeks after planned EOT.

  2. Percentage of Participants With On-treatment Virologic Failure

    Time frame: up tp 24 weeks

    On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with HCV RNA greater than 15 IU/ml

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 14, 2020
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.