NCT04382339

Brief Summary

This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

May 6, 2020

Last Update Submit

May 6, 2020

Conditions

Hepatitis C Virus Infection

Keywords

HCV genotype 4sofosbuvirPeg-interferon α-2ribavirinEgyptian patientsExperincedNaive

Outcome Measures

Primary Outcomes (2)

  • 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) \< 15 IU/m 12 weeks after the last dose of drugs.

    12 weeks after last dose

  • Number of Participants With Adverse Events in Each Treatment Arm

    An adverse event (AE) is defined as any untoward medical occurrence in a participant or i 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

    Screening until 30 days after last dose

Secondary Outcomes (2)

  • Percentage of Participants With Viral relapse

    12 weeks after last dose

  • Percentage of Participants With On-treatment Virologic Failure

    up tp 24 weeks

Study Arms (2)

Treatment-naive

ACTIVE COMPARATOR

Naive Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2)

Drug: SOF/RBV/PegINFα-2

Treatment-experienced

ACTIVE COMPARATOR

Experienced Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2)

Drug: SOF/RBV/PegINFα-2

Interventions

SOF/RBV/PegINFα-2DRUG

SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFα-2: chemically modified form of the standard interferon that treats hepatitis C

Treatment-experiencedTreatment-naive

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study population consisted of treatment-naïve and treatment-experienced adults patients aged 20-65 with HCV RNA level \> 10,000 IU/ml.
  • Experienced participants included those with a prior relapse or a null response to PegINF/RBV therapy.

You may not qualify if:

  • HCV coinfected with hepatitis B virus (HBV)
  • human immunodeficiency virus (HIV)
  • had any liver disease other than chronic HCV GT4 infection.
  • had a history of liver decompensation
  • serum a-fetoprotein (AFP) \> 100 ng/ml
  • evidence of hepatocellular carcinoma
  • major severe illness such as respiratory, renal, heart failure or autoimmune disease
  • non-compliance with treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Abdel-Moneim A, Abood A, Abdel-Gabaar M, Zanaty MI, Ramadan M. Effectiveness of sofosbuvir/pegylated-interferon plus ribavirin in treatment of hepatitis C virus genotype 4 patients. Clin Exp Hepatol. 2018 Sep;4(3):191-196. doi: 10.5114/ceh.2018.78123. Epub 2018 Sep 10.

    PMID: 30324144RESULT

Related Links

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 11, 2020

Study Start

March 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

May 11, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share