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Completed

NCT Number: NCT04391985

Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients

enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beni-Suef University

Banī Suwayf, Egypt

About this study

Enrolled participants were treated orally with SOF plus a fixed dose combination of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir plus Ribavirin (OBV/PTV/r plus RBV), which was administered orally based on the participants' tolerability. The primary end point was a sustained virological response (HCV RNA level < 15 IU/ mL), observed 12 weeks after the end of the treatment (SVR12).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The experienced participants who were treated previously with (SOF/DCV) , (SOF/SMV), (SOF/RBV), or (SOF/pegINF/RBV).
  • The presence of compensated liver cirrhosis was documented by ultrasonographic examination, liver biopsy, results of Fibroscan or FIB-4 score, and laboratory markers, like FIB-4 > 3.25 (advanced fibrosis or cirrhosis), albumin < 3.5, total bilirubin > 1.2, and also confirmed by clinical characteristics such as lower limb edema, splenomegaly, esophageal varices.

Exclusion criteria

  • liver disease of non-HCV GT4 etiology, coinfection with hepatitis B or HIV
  • poorly controlled diabetes (HbA1C > 8)
  • participants, hepatocellular carcinoma, a history of extrahepatic malignancy in the 5 years prior to the study
  • renal failure
  • evidence of hepatic decompensation
  • blood picture abnormalities such as anemia (hemoglobin concentration of < 10 g/dL)
  • thrombocytopenia (platelets count < 50,000 cells/mm3).
  • major severe illness such as congestive heart failure and respiratory failure.

Treatment and study plan

SOF plus (OBV/PTV/r) plus RBV

Drug

They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability.

Other names: Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease, Sovaldi is a trade name of sofosbuvir, Ombitasvir (ABT 267) is an NS5A inhibitor

Primary outcomes

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

    Time frame: 12 weeks after last dose

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

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

    Time frame: Screening up to 12 weeks after last dose]

    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: Up to 12 weeks after last dose

    Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( > 15 IU/ml) levels 12 weeks after planned EOT.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 18, 2020
Registry last updated
May 18, 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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