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Completed

NCT Number: NCT04378608

Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4

The objective of the investigators was to delineate the efficacy and safety of Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) plus ribavirin (RBV) on chronic HCV GT4 Egyptian naïve patients

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Key information

About this study

Direct-acting antivirals (DAAs) combination therapies from various mechanisms of action and families have been revolutionized the management landscape of chronic hepatitis C virus (HCV). Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) ± ribavirin (RBV) are approved to treat HCV genotype 4 (GT4) infection. Here, investigators' objective was to delineate the efficacy and safety of OBV/PTV/r plus RBV of HCV GT4 in the treatment of Egyptian naïve patients.

Between 5 January and 8 September 2017, a cohort of 100 Egyptian patients infected with HCV GT4 was allocated and administered orally OBV/PTV/r with RBV, for 12 weeks, which given as oral tablets based on patient tolerability. The primary endpoint of investigators' study was a sustained virological response (HCV RNA < 12 IU/mL) 12 weeks from the cessation of the treatment (SVR12).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Treatment-naïve patients with HCV GT4 with plasma HCV RNA level >10,000 IU/ml

Exclusion criteria

  • Hepatitis of non-HCV cause
  • Coinfection with other than HCV GT4
  • Poorly controlled diabetics (HbA1C >8) patients
  • a history of extra-hepatocellular malignancy in the last 5 years
  • Major severe illness such as congestive heart failure, respiratory failure, evidence of hepatic decompensation.
  • Laboratory and blood picture abnormalities such as anemia (hemoglobin concentration of 10 <g/dl) and thrombocytopenia (platelets <50,000 cells/mm3) and (serum albumin <2.8 g/dL, international normalized ratio (INR) of > 2.3, serum total bilirubin concentration of >3.0 mg/dL.

Treatment and study plan

OBV/PTV/r) ± ribavirin (RBV)

Drug

Other names: Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease Ombitasvir (ABT 267) is an NS5A inhibitor

Primary outcomes

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

    Time frame: 12 weeks after last dose

    SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 12 IU/mL 12 weeks after the last dose of study drug.

  2. adverse event (AE)

    Time frame: Screening up to 30 days after last dose

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation observed after administering a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in, death, participant hospitalization, life-threatening, significant disability/incapacity, or a congenital anomaly.

Secondary outcomes

  1. Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment

    Time frame: Up to 12 weeks after last dose

    Post-treatment relapse was defined as defined as confirmed HCV RNA > 12 IU/ml between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < 12 IU/ml at the end of treatment.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Efficacy of Ombitasvir With Paritaprevir/Ritonavir Plus Ribavirin on the Treatment naïve Patients With Chronic Hepatitis C Virus Genotype 4

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 7, 2020
Registry last updated
May 12, 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.

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