Status:
WITHDRAWN
Ledipasvir/Sofosbuvir Treatment for Hepatitis C in HCT Recipients.
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
City of Hope National Medical Center
Conditions:
Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The prevalence of Hepatitis C Virus (HCV) infection was reported to range between 10% and up to 30% prior to institution of routine HCV screening in recipients of HCT (hematopoietic cell transplantati...
Detailed Description
This is an open-label observational/ feasibility study to treat candidates for HCT infected with hepatitis C prior to the transplantation to reduce the complications associated with hepatitis C in the...
Eligibility Criteria
Inclusion
- Participant must be male or female at least 18 years of age at time of screening
- Participant must be able to provide written Informed Consent
- Participant must be able to adhere to study visit/procedure schedule and protocol requirements
- Time available (at least 12 weeks) for treatment of hepatitis C prior to autologous or allogeneic transplantation
- First autologous or allogeneic HCT and hematologic disease in remission on initiation of antiviral therapy for hepatitis C infection
- Patients with myelodysplastic syndrome, aplastic anemia or hemoglobinopathies will be eligible to participate regardless of disease status if plan is to proceed to HCT
- Female participant without childbearing potential must meet at least one of the following:
- Postmenopausal defined as women \>54 years of age with amenorrhea for ≥ 2 years prior to screening
- Surgically sterile defined as bilateral tubal ligation or bilateral oophorectomy or hysterectomy
- Has male sexual partner with vasectomy
- Female participant of childbearing potential must meet at least one of the following:
- Must be using at least 1 effective contraceptive method at screening and agree to practice 2 effective contraceptive methods1 for study duration, starting Screening through 30 days after stopping study drug
- Practice total abstinence from sexual intercourse (minimum 1 complete menstrual cycle)
- Sexually active with female partner only
- Male participant who is not surgically sterile and is sexually active with female partner of childbearing potential must agree to practice 2 effective contraceptive methods1 for study duration, starting at Screening through 30 days after stopping study drug
- Participant must have the following indicator- of chronic hepatitis C virus infection prior to study enrollment:
- • Positive for HCV RNA at the time of screening
- Participant screening laboratory result must indicate HCV genotype 1, 4, 5 or 6-infection if historical result is not available.
Exclusion
- Participant unwilling to provide written informed consent
- Participant unwilling to adhere to study visit/procedure schedule and protocol requirements
- Participant is pregnant or is a breastfeeding female
- Positive test result for hepatitis B surface antigen (HBsAG), hepatitis B core antibody (HBcAb), or confirmed positive anti-HIV antibody test
- Received study contraindicated medications prior to study drug administration including but not limited to those listed in the Full Prescribing Information Sheet for ledipasvir/sofosbuvir (Harvoni®).
- Clinically significant abnormalities or co-morbidities, other than HCV infection that in opinion of the investigator makes subject unsuitable for this study or drug regimen
- Prior or current use of any investigational or commercially available anti-HCV agents other than interferon or ribavirin or receipt of any investigational product within 6 weeks prior to study drug administration
- Prior treatment of chronic HCV infection with a direct acting antiviral agent(s): telaprevir, boceprevir, sofosbuvir, simeprevir, or other direct acting antiviral
- History of solid organ transplant
- Screening laboratory analyses shows any of the following abnormal laboratory results:
- Estimated Glomerular filtration (eGFR) rate \< 30 mL/min
- Evidence of cirrhosis, documented by one of the following:
- Liver biopsy histologic diagnosis: Metavir Score greater than 3 (includes 3 - 4 or ¾) or Ishak score greater than 4 In the absence of liver biopsy: a FibroScan score greater than or equal to 12.5 kPa or Fibrotest score of \>0.75 AND an APRI score greater than 1.5
- History of liver decompensation: ascites noted on a physical exam, imaging or other test; variceal bleeding; hepatic encephalopathy
- Confirmed presence of hepatocellular carcinoma indicated on computed tomography, magnetic resonance, or other imaging techniques within 3 months prior to screening
- HCV genotype performed during screening indicates infection with genotype 2 or 3
- Recent history of drug or alcohol abuse that could, in the opinion of the investigator, affect adherence to the study protocol
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03279133
Start Date
September 1 2017
End Date
April 29 2018
Last Update
August 31 2018
Active Locations (2)
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1
City of Hope
Duarte, California, United States, 91010
2
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027