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Trial record 44 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy

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ClinicalTrials.gov Identifier: NCT02638233
Recruitment Status : Unknown
Verified December 2015 by Michael Gschwantler, Wilhelminenspital Vienna.
Recruitment status was:  Recruiting
First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Michael Gschwantler, Wilhelminenspital Vienna

Brief Summary:
Patients with chronic hepatitis C that are under opiate substitution therapy are likely to have psychiatric comorbidities such as depression; hence an Interferon based therapy is contraindicated. Additionally many of these patients have a borderline compliance, which makes it impossible to treat them at specialized hepatological centers. An ideal opportunity to treat this patients is treatment with DAAs (Direct Acting Antiviral) which can be administered daily together with the opiate substitution therapy at a low threshold facility.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Sofosbuvir 400mg / Ledipasvir 90 mg (FDC) Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Direct Observed Therapy With Ledipasvir/Sofosbuvir in Treatment-naïve Patients With Chronic Genotype 1 HCV (Hepatitis C Virus) Infection Receiving Opiate Substitution Therapy
Study Start Date : September 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Sofosbuvir 400mg/Ledipasvir 90 mg
Subjects will receive sofosbuvir 400mg q.d p.o and ledipasvir 90 mg q.d p.o (FDC) for 8 weeks
Drug: Sofosbuvir 400mg / Ledipasvir 90 mg (FDC)
Other Name: Harvoni




Primary Outcome Measures :
  1. Percentage of pills taken during the treatment phase will be calculated as a parameter for adherence to therapy for each individual subject. [ Time Frame: 8 Weeks ]
    Study drugs will administered daily together with the opiate substitution therapy under the supervision of qualified site personnel and recorded on a worksheet for each subject. At the end of the treatment phase, the total number of DAA pills taken will be assessed as percentage for each subject and for the whole study population.


Secondary Outcome Measures :
  1. Sustained Virologic Response (SVR) 12 Weeks after End of Therapy (SVR 12) [ Time Frame: 12 Weeks after end of Therapy ]
    Viral load will be measured via PCR 12 Weeks after the End of Therapy

  2. Sustained Virologic Response (SVR) 24 Weeks after End of Therapy (SVR 24) [ Time Frame: 24 Weeks after end of Therapy ]
    Viral load will be measured via PCR (polymerase chain reaction) 24 Weeks after the End of Therapy

  3. Safety and tolerability (total number of observed adverse events) [ Time Frame: 20 weeks ]
    Safety and tolerability of Ledipasvir/Sofosbuvir in patients with chronic hepatitis C under opiate substitution therapy at a low threshold facility will be assessed by reporting total number of adverse event and laboratory abnormalities observed in each patient. Total number of observed adverse events and laboratory abnormalities will be reported tabulated by body system. Adverse events will be observed during the 8 weeks treatment phase and the 12 week follow up phase, for a total duration of 20 weeks.



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

Inclusion Criteria:

  • Chronic genotype 1 HCV infection
  • Fibrosis F0-F3 (i.e. non-cirrhotic confirmed by Fibroscan <12.5kPa)
  • Stable opiate substitution therapy
  • Regular visits at the low threshold facility during the last month

Exclusion Criteria:

  • Lack or unwillingness of safe contraception, pregnancy
  • Liver cirrhosis (Fibroscan ≥12.5kPa)
  • Coinfection with HBV (Hepatitis B Virus) or HIV (coinfection with HIV is excluded only because there are very few coinfected patients under care at the "Ambulatorium Suchthilfe Wien" and hence this subpopulation would be very small)
  • Severe comorbidities resulting in a life expectancy of less than five years
  • HCC (Hepatocellular carcinoma)

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): NCT02638233


Contacts
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Contact: Michael Gschwantler, Prof. MD 0043 1 49150 2401 michael.gschwantler@wienkav.at
Contact: Johann Haltmayer, MD, HCM 0043 1 4000 53603 hans.haltmayer@sd-wien.at

Locations
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Austria
Wilhelminenspital Recruiting
Vienna, Austria, 1160
Contact: Michael Gschwantler, Prof. MD    0043 1 491502401    michael.gschwantler@wienkav.at   
Contact: Johann Haltmayer, MD, HCM    0043 1 4000 53 603    hans.haltmayer@sd-wien.at   
Sponsors and Collaborators
Wilhelminenspital Vienna
Gilead Sciences
Investigators
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Principal Investigator: Michael Gschwantler, Prof. MD Wilhelminenspital Vienna

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Gschwantler, Prof.Dr, Wilhelminenspital Vienna
ClinicalTrials.gov Identifier: NCT02638233     History of Changes
Other Study ID Numbers: WIL4ME2015/01
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Keywords provided by Michael Gschwantler, Wilhelminenspital Vienna:
CHC
IVDA (intravenous drug abuse)
Hepatitis C
Sofosbuvir
Ledipasvir
Opiate Substitution Therapy
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Hepatitis, Chronic
Sofosbuvir
Opiate Alkaloids
Antiviral Agents
Anti-Infective Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents