NCT03061032

Brief Summary

Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is one of the public health problems resulting in chronic liver disease, cirrhosis and hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to prevent advanced liver diseases. The previous Pegylated-interferon and Ribavirin therapy was not efficient in all cases and results in numerous number of side-effects. Introduction of direct acting antiviral agents (DAAs) such as Sofosbuvir and Ledipasvir make the eradication of HCV possible however these regimens are not affordable and available in developing countries. The generic DAAs are manufactured in many of these countries such as Iran to provide the treatment with reasonable price.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2017

Status
unknown

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

February 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

February 13, 2017

Last Update Submit

February 17, 2017

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Sustained Virologic Response

    Undetectable HCV RNA 12 weeks after completion of treatment with RT-PCR or TMA with a 15 IU/mL limit of detection

    12 weeks after completion of treatment

Study Arms (4)

Sofosbuvir/Ledipasvir for 12W

EXPERIMENTAL

Patients without cirrhosis and previous history of treatment will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.

Drug: Sofosbuvir/Ledipasvir 12W

Sofosbuvir/Ledipasvir+Ribavirin for 12W

EXPERIMENTAL

Patients with compensated cirrhosis and/or previous history of treatment will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.

Drug: Sofosbuvir/Ledipasvir plus Ribavirin 12W

Sofosbuvir/Ledipasvir for 24W

EXPERIMENTAL

Patients with compensated or decompensated cirrhosis and/or previous history of treatment and with contraindication of Ribavirin will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.

Drug: Sofosbuvir/Ledipasvir 24W

Sofosbuvir/Ledipasvir+Ribavirin for 24W

EXPERIMENTAL

Patients with decompensated cirrhosis will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.

Drug: Sofosbuvir/Ledipasvir plus Ribavirin 24W

Interventions

Sofosbuvir/Ledipasvir 12WDRUG

Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.

Sofosbuvir/Ledipasvir for 12W
Sofosbuvir/Ledipasvir plus Ribavirin 12WDRUG

Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.

Sofosbuvir/Ledipasvir+Ribavirin for 12W
Sofosbuvir/Ledipasvir 24WDRUG

Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.

Sofosbuvir/Ledipasvir for 24W
Sofosbuvir/Ledipasvir plus Ribavirin 24WDRUG

Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.

Sofosbuvir/Ledipasvir+Ribavirin for 24W

Eligibility Criteria

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

You may qualify if:

  • Chronic HCV infection
  • \>18 years old

You may not qualify if:

  • HIV co-infected
  • Liver transplanted
  • Receiving drugs with suspected interactions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvirledipasvir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Seyed Moayed Alavian, MD

    Iran Hepatitis Network

    STUDY CHAIR

  • Heidar Sharafi, PhD

    Iran Hepatitis Network

    STUDY DIRECTOR

  • Bita Behnava, MD

    Iran Hepatitis Network

    PRINCIPAL INVESTIGATOR

  • Mohammad Saeid Rezaee-Zavareh, MD

    Iran Hepatitis Network

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyed Moayed Alavian, MD

CONTACT

+989121073195alavian@thc.ir

Heidar Sharafi, PhD

CONTACT

+989125176030h.sharafi@meldcenter.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 23, 2017

Study Start

March 1, 2017

Primary Completion

December 1, 2018

Study Completion

July 1, 2019

Last Updated

February 23, 2017

Record last verified: 2017-02