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Trial record 94 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC (FRI-STC)

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ClinicalTrials.gov Identifier: NCT02771405
Recruitment Status : Unknown
Verified May 2016 by Mohamed Hassany, National Hepatology & Tropical Medicine Research Institute.
Recruitment status was:  Recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Mohamed Hassany, National Hepatology & Tropical Medicine Research Institute

Brief Summary:
The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients will undergo treatment with different regimens of DAAs.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Hepatocellular Carcinoma Drug: Sofosbuvir Drug: Ribavirin Drug: Simeprevir Drug: daclatasvir Drug: Ledipasvir Phase 3

Detailed Description:

The study will recruit 150 patients with HCV related HCC All the studied patients underwent or will undergo one of the curative interventions for HCC either hepatic resection or thermal ablation .

after 1 month of achievement of laboratory and radiological response to HCC intervention the patient will be treated with one of the interferon free regimens :

  1. Sofosbuvir+Ribavirin
  2. Sofosbuvir+Simeprevir± Ribavirin
  3. Sofosbuvir+ Daclatasvir ± Ribavirin
  4. Sofosbuvir+ Ledipasvir ± Ribavirin

the treatment duration will be justified either 12 or 24 weeks after treatment the patient will continue on regular follow up to detect HCV cure or recurrence , HCC cure or recurrence and long term follow up of natural history


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC
Study Start Date : March 2016
Estimated Primary Completion Date : February 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: Sofosbuvir +Ribavirin
Sofosbuvir 400 mg/day +ribavirin for 24 weeks
Drug: Sofosbuvir
Sofosbuvir 400 mg orally once daily
Other Names:
  • Sovaldi®
  • GS-7977

Drug: Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Names:
  • Copegus®
  • Rebetol®

Experimental: Sofosbuvir+Simeprevir±Ribavirin
Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks
Drug: Sofosbuvir
Sofosbuvir 400 mg orally once daily
Other Names:
  • Sovaldi®
  • GS-7977

Drug: Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Names:
  • Copegus®
  • Rebetol®

Drug: Simeprevir
Simeprevir 150 mg orally once daily
Other Names:
  • Olysio®
  • TMC435

Experimental: Sofosbuvir+Daclatasvir±Ribavirin
Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks
Drug: Sofosbuvir
Sofosbuvir 400 mg orally once daily
Other Names:
  • Sovaldi®
  • GS-7977

Drug: Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Names:
  • Copegus®
  • Rebetol®

Drug: daclatasvir
Daclatasvir 60 mg orally once daily
Other Names:
  • clatazev®
  • BMS-790052

Experimental: Sofosbuvir+Ledipasvir±Ribavirin
Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks
Drug: Sofosbuvir
Sofosbuvir 400 mg orally once daily
Other Names:
  • Sovaldi®
  • GS-7977

Drug: Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Names:
  • Copegus®
  • Rebetol®

Drug: Ledipasvir
Ledipasvir 90 mg orally once daily
Other Name: Co-formulated with Sofosbuvir in one tablet (Harvoni ® )




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment [ Time Frame: 12 weeks after the last dose of study drugs ]

Secondary Outcome Measures :
  1. Percentage of participants with virologic failure during treatment or relapse after treatment [ Time Frame: from baseline until 12 weeks after the last dose of study drugs ]
  2. Percentage of Participants who will show any radiological or laboratory changes denoting local or denovo recurrence of HCC [ Time Frame: Follow up will be done from baseline for up to 36 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-70 years old
  • Confirmed HCV viremia by PCR
  • CHILD Pugh "A" or "B7,B8"
  • Confirmed HCC either by laboratory ,imaging or histopathological criteria
  • Underwent or candidate for curative intervention for HCC (BCLC stage 0 ,A)
  • Willing to be treated for HCV and signing informed consent

Exclusion Criteria:

  • Patients below 18 or above 70 years old
  • patients with advanced liver condition "CHILD score ≥ B9"
  • Patients with advanced HCC status (BCLC≥ B)
  • Patients with combined HBV ,HIV infection

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 ClinicalTrials.gov identifier (NCT number): NCT02771405


Contacts
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Contact: Mohamed Hassany, MD. +2 01128500015 mohamadhassany@yahoo.com
Contact: Aisha El Sharkawy, MD +2 01222211004 a_m_sharkawy@yahoo.com

Locations
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Egypt
Amr Maged Recruiting
Cairo, Egypt, 11441
Contact: Amr Maged       amrrasheed88@gmail.com   
Sponsors and Collaborators
National Hepatology & Tropical Medicine Research Institute
Cairo University
Investigators
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Principal Investigator: Gamal Esmat, MD. Cairo University
Study Director: Aisha El Sharkawy, MD Cairo University
Study Director: Mohamed Hassany, MD National Hepatology & Tropical Medicine Research Institute (NHTMRI)
Study Director: Mai Mehrez, MD. National Hepatology & Tropical Medicine Research Institute (NHTMRI)
Study Chair: Amr Maged National Hepatology & Tropical Medicine Research Institute (NHTMRI)

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mohamed Hassany, Hepatology & Gastroenterology Consultant , Director of HCC Unit, National Hepatology & Tropical Medicine Research Institute
ClinicalTrials.gov Identifier: NCT02771405     History of Changes
Other Study ID Numbers: 4/2016
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mohamed Hassany, National Hepatology & Tropical Medicine Research Institute:
HCV-HCC-DAAs
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Hepatitis C
Hepatitis C, Chronic
Carcinoma, Hepatocellular
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepatitis, Chronic
Interferons
Ribavirin
Sofosbuvir
Simeprevir
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors