Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4

NCT04378608 | Completed Phase 1 DMC

• 1 other identifier: Qu2018
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hepatitis C Virus Infection

Keywords

Ombitasvir; Paritaprevir; Ritonavir; Ribavirin; HCV; Genotype 4; Naïve; Egyptians

Outcome Measures

Primary Outcomes (2)

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

  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.

  12 weeks after last dose

• adverse event (AE)

  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.

  Screening up to 30 days after last dose

Secondary Outcomes (1)

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

  Up to 12 weeks after last dose

Study Arms (1)

2 DAA (OBV/PTV/r) ± ribavirin (RBV)

OTHER

Administering Ombitasvir/Paritaprevir/Ritonavir/ tablets plus RBV tablets to HCV GT4 in the treatment of Egyptian naïve patients

Drug: OBV/PTV/r) ± ribavirin (RBV)

Interventions

OBV/PTV/r) ± ribavirin (RBV) DRUG

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

2 DAA (OBV/PTV/r) ± ribavirin (RBV)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Related Publications (1)

• Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty M, Ramadan M. Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients. Dig Dis Sci. 2018 May;63(5):1341-1347. doi: 10.1007/s10620-018-5005-8. Epub 2018 Mar 15.

  PMID: 29546644 BACKGROUND

Related Links

• This link clarify the retreatment efficacy and safety of SOF with OBV/PTV/r + RBV, for chronic HCV GT4-experienced patients who failed treatment with DAA-based regimens

MeSH Terms

Conditions

Hepatitis C

Interventions

Ribavirin; paritaprevir; ombitasvir

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)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mohammed Abdel-Gabbar, Ass. Prof

  Biochemistry Dep., Faculty of Science, Beni-Suef University, P.O. Box 52621

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof

Model Details: 100 Egyptian naive patients infected with HCV GT4 was allocated and administered orally OBV/PTV/r with RBV which given as oral tablets based on patient tolerability

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 7, 2020
• Study Start: January 5, 2017
• Primary Completion: September 8, 2017
• Study Completion: September 8, 2017
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share