Status:
COMPLETED
Phase 1b/2, Open Label, Repeat Dose, Dose Escalation Study of ND-L02-s0201 Injection in Subjects With Moderate to Extensive Fibrosis (METAVIR F3-4)
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Nitto Denko Corporation
Conditions:
Moderate to Extensive Hepatic Fibrosis (METAVIR F3-4)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of multiple doses of ND-L02-s0201 in subjects with moderate to extensive hepatic fibrosis.
Eligibility Criteria
Inclusion
- Male or female between 18 and 75 years
- Diagnosis of METAVIR F3-4 hepatic fibrosis determined by liver biopsy done within 12 months before screening (Cohort 1) or at the pre-dose biopsy within 6 weeks before treatment (Cohorts 2 and 3)
- Adequate and stable synthetic hepatic function (albumin ≥ 3 g/dL, international normalized ratio \[INR\] ≤ 1.4 x upper limit of normal \[ULN\] and stable by prior medical history).
- Adequate and stable hepatic function as measured by alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate transaminase (AST), gamma glutamate transferase (GGTP), and total bilirubin (ALT/AST ≤ 5 x ULN, ALP ≤ 4 x ULN, GGTP ≤ 4 x ULN, bilirubin ≤ 2x ULN and stable by prior medical history).
- Platelet count ≥ 75,000/mm3, hemoglobin ≥ 10 g/dL, and white blood cell count (WBC) \> 3000/µL.
- No signs of decompensated liver disease (ascites, hepatic encephalopathy, or variceal bleeding).
- No clinically significant abnormalities on 12-lead electrocardiogram (ECG).
- No other intercurrent medical conditions or infections considered clinically significant by the Investigator.
- Clinical laboratory assessments are within the laboratory limits of normal values or not considered clinically significant by the Investigator.
- Vitamin A levels at screening must be less than or equal to the upper limit of normal (ULN 95 µg/dL or 3.32 µmol/L).
- Any male subject, if sexually active, agrees to use barrier contraceptive techniques as defined in the protocol. If female, the subject must be of non-childbearing potential as defined in the protocol.
- Subjects who are active substances abusers may be enrolled at the discretion of the Principal Investigator.
- Willing and able to provide written informed consent and comply with the study procedures and visit schedule, including follow up visits.
Exclusion
- Any disease or condition which, in the opinion of the Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of ND L02 s0201, or would place the subject at increased risk.
- On ongoing therapy for HCV/HBV, or received therapy for HCV/HBV within 12 weeks prior to administration of study drug.
- On interferon therapy for any disease or received interferon therapy for any disease within 12 weeks prior to administration of study drug.
- History of bone disease, including osteoporosis and osteomalacia, Paget's disease of bone, or a history of unexplained fractures or fractures after minimal trauma.
- Alpha-fetoprotein (AFP) ≥ 50 ng/mL or signs of abnormality or hepatocellular carcinoma on ultrasound survey of the liver.
- Carcinoembryonic antigen (CEA) levels above the ULN.
- Laboratory test results include abnormal values considered to be clinically significant by the Investigator.
- Participated in a concurrent interventional study with the last intervention occurring within 12 weeks prior to administration of study drug.
- Taken vitamin A or vitamin D supplements or multi-vitamins that contain vitamin A or vitamin D between the screening visit and administration of study drug.
- History, within the last 2 years, of alcohol abuse, significant mental illness, or physical dependence on any opioid.
- Veins unsuitable for repeated venipuncture or IV infusion (eg, veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).
- Received recent treatment with alternative therapies, which, in the opinion of the Investigator, could potentially confound clinical or laboratory assessments.
- Lost more than 500 mL of blood within 56 days prior to administration of study drug.
- Body mass index (BMI) \> 38 kg/m2.
- History of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness (AIDS).
- History of malignancy within the last 5 years with the exception of basal cell carcinoma.
- Woman of childbearing potential.
- History of hypersensitivity to H2-receptor antagonists.
- Any other reason that, in the opinion of the Investigator or the Sponsor's Medical Monitor, makes the subject unsuitable for enrollment.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02227459
Start Date
October 1 2014
End Date
May 1 2016
Last Update
May 11 2017
Active Locations (2)
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1
Texas Liver Institute
Austin, Texas, United States, 78215
2
Tokuda Hospital
Sofia, Bulgaria