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Trial record 41 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03169348
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : December 7, 2017
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

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

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: sofosbuvir daclatasvir Drug: Ledipasvir/sofosbuvir Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: study group
Hepatitis- C virus with thrombocytopenia
Drug: sofosbuvir daclatasvir
oral tablets

Drug: Ledipasvir/sofosbuvir
oral tablets

Primary Outcome Measures :
  1. the mean difference on the platelet count [ Time Frame: 6 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hepatitis C virus infection and thrombocytopenia before treatment

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03169348

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Assiut University Recruiting
Assiut, Egypt, 71111
Contact: Ahmed Abbas, MD    00201003385183   
Sponsors and Collaborators
Assiut University

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Responsible Party: Ahmed Mohamed Abbas, principal investigator, Assiut University Identifier: NCT03169348     History of Changes
Other Study ID Numbers: HCV
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir, sofosbuvir drug combination
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Blood Platelet Disorders
Hematologic Diseases
Antiviral Agents
Anti-Infective Agents