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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04387526
Other study ID # SOF-DCV-RBV
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date April 1, 2016
Est. completion date May 31, 2017

Study information

Verified date May 2020
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 946
Est. completion date May 31, 2017
Est. primary completion date May 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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-a-/RBV, SOF/peg-IFN-a +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.

Study Design


Intervention

Drug:
(SOF and DCV)

(SOF, DCV, and RBV)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

References & Publications (1)

Abdel-Moneim A, Aboud A, Abdel-Gabaar M, Zanaty MI, Ramadan M. Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin: large real-life results of patients with chronic hepatitis C genotype 4. Hepatol Int. 2018 Jul;12(4):348-355. doi: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12 SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/m 12 weeks after the last dose of drugs. 12 weeks after last dose
Primary Number of Participants With Adverse Events in Each Treatment Arm 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
up for 12 weeks after planned End of Treatment (EOT).
Secondary Percentage of Participants With Viral relapse Viral relapse was HCV RNA level = 15 IU/ml at EOT, but detectable HCV RNA level > 15 IU/ml 12 weeks after planned EOT. 12 weeks after last dose
Secondary Percentage of Participants With On-treatment Virologic Failure On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with HCV RNA greater than 15 IU/ml up tp 24 weeks
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