Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy
|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. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Sofosbuvir 400mg / Ledipasvir 90 mg (FDC)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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
- 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
- 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.
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
|Contact: Michael Gschwantler, Prof. MD||0043 1 49150 email@example.com|
|Contact: Johann Haltmayer, MD, HCM||0043 1 4000 firstname.lastname@example.org|
|Principal Investigator:||Michael Gschwantler, Prof. MD||Wilhelminenspital Vienna|