NCT03032666

Brief Summary

Sustained Viral Response following 12-week therapy (SVR 12) with sofosbuvir/ledipasvir in transfusion-dependent patients with HCV genotype 1-6 Secondary Objective(s): Assessment of transfusion requirements Adverse events Efficacy in treatment-naïve vs. relapsers vs. null responders Efficacy in patients with advanced fibrosis/cirrhosis vs. F1, F2 by elastography

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2017

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

First Submitted

Initial submission to the registry

January 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

January 24, 2017

Last Update Submit

October 10, 2018

Conditions

ThalassemiaHepatitis C

Keywords

ThalassemiaHCVSofosbuvirLedipasvir

Outcome Measures

Primary Outcomes (1)

  • Sustained Viral Response following 12-week therapy (SVR 12) with sofosbuvir/velpatasvir in transfusion-dependent patients with HCV genotype 1-6

    Via tests of HepC RNA levels

    12 weeks

Study Arms (1)

sofosbuvir/velpatasvir

EXPERIMENTAL

Epclusa

Drug: sofosbuvir/velpatasvir

Interventions

sofosbuvir/velpatasvirDRUG

treatment of hepatitis C genotype 1-6 in patients with transfusion-dependent thalassemia.

Also known as: Epclusa
sofosbuvir/velpatasvir

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Transfusion Dependent thalassemia patients with HCV genotype 1-6
  • Age ≥18
  • Male and female
  • No evidence of hepatocellular carcinoma on ultrasound
  • No known drug allergy to the FDA approved drug to be used
  • Adequate iron chelation therapy
  • Compensated liver disease

You may not qualify if:

  • Age below 18
  • Chronic HCV genotypes 2 or 3
  • Allergy to study drug
  • Hepatocellular carcinoma
  • Inadequate iron chelation therapy
  • Decompensated liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

ThalassemiaHepatitis C

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Head of Gastroenterology Department

Study Record Dates

First Submitted

January 24, 2017

First Posted

January 26, 2017

Study Start

May 1, 2017

Primary Completion

August 6, 2018

Study Completion

August 6, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)