NCT04387539

Brief Summary

Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

May 10, 2020

Last Update Submit

May 10, 2020

Conditions

Chronic Hepatitis C Virus Infection

Keywords

Chronic HCV GT4SofosbuvirSimeprevirDaclatasvirRibavirinExperienced

Outcome Measures

Primary Outcomes (2)

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

    SVR12 is 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

  • 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

    Screening up to 12 weeks after last dose

Secondary Outcomes (1)

  • Percentage of Participants With Viral relapse

    Up to 12 weeks after last dose

Study Arms (2)

Non-Cirrhotic

ACTIVE COMPARATOR

SOF plus DCV/SMV/RBV regimen was administered to Egyptian non-cirrhotic experienced HCV GT4 participants for 12 weeks

Drug: SOF/SMV/DCV/RBV

Cirrhotic

ACTIVE COMPARATOR

SOF plus DCV/SMV/RBV regimen was administered to Egyptian cirrhotic experienced HCV GT4 participants for 12 weeks

Drug: SOF/SMV/DCV/RBV

Interventions

SOF/SMV/DCV/RBVDRUG

SOF was given orally at a dose of 400 mg/day DCV was given orally at a dose of 60 mg/day SMV was given orally at a dose of 150 mg/day. RBV was given in a total daily oral dose of 600 mg/day up to 1,200 mg/day according to the participant's weight and tolerability.

Also known as: Olysio is a trade name of simeprevir, Sovaldi is a trade name of sofosbuvir, Daklinza is a trade name of daclatasvir
CirrhoticNon-Cirrhotic

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experienced Egyptian participants with HCV GT4 infection who had failed prior DAA treatments \[SOF/DCV or SOF/SMV or SOF/pegylated interferon/RBV or SOF/RBV\]
  • Fibrosis-4 score in non-cirrhotic participants is \<1.45-3.25: (None or moderate fibrosis)
  • Fibrosis-4 score in cirrhotic participants is \>3.25: (Advanced fibrosis or cirrhosis)

You may not qualify if:

  • HCV coinfected with hepatitis B virus (HBV) or 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

Study Sites (1)

Health Administration at Beni-Seuf

Bani Sweif, Egypt

Location

Related Publications (1)

  • Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty MI, Ramadan M. A sofosbuvir-based quadruple regimen is highly effective in HCV type 4-infected Egyptian patients with DAA treatment failure. J Hepatol. 2018 Jun;68(6):1313-1315. doi: 10.1016/j.jhep.2018.03.010. Epub 2018 Apr 3. No abstract available.

    PMID: 29625827RESULT

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 10, 2020

First Posted

May 14, 2020

Study Start

March 1, 2017

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

May 14, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)