NCT03169348

Brief Summary

Autoimmune thrombocytopenic purpura is an immunological disorder characterized by increased platelet destruction due to presence of anti-platelet antibodies. Hepatitis C virus infection, which is one of the most common chronic viral infections worldwide, may cause secondary chronic immune thrombocytopenic purpura. It seemed to play a pathogenic role in autoimmune thrombocytopenic purpura. Moreover, the successful response (negative hepatitis C virus - ribonucleic acid) to tapered steroids and antiviral therapy was useful to revert thrombocytopenia

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

May 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

1.6 years

First QC Date

May 25, 2017

Last Update Submit

December 6, 2017

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • the mean difference on the platelet count

    6 month

Study Arms (1)

study group

EXPERIMENTAL

Hepatitis- C virus with thrombocytopenia

Drug: sofosbuvir daclatasvirDrug: Ledipasvir/sofosbuvir

Interventions

sofosbuvir daclatasvirDRUG

oral tablets

study group
Ledipasvir/sofosbuvirDRUG

oral tablets

study group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hepatitis C virus infection and thrombocytopenia before treatment

You may not qualify if:

  • Infection Hepatitis B virus
  • Hypersplenism
  • Diseases affecting Bone marrow
  • Major clotting factors abnormalities eg. Disseminated intravascular coagulopathy, severe Prothrombin deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Interventions

ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 30, 2017

Study Start

November 1, 2017

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

December 7, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)