The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection

Study Overview
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Brief Summary
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Primary Objective: To determine the P1101 pharmacokinetic (PK) profile at the single dose of 400 μg.

Detailed Description
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Secondary Objective: To determine the safety and immunogenicity of P1101 400 μg subcutaneous (SC) single dose + Ribavirin 800-1400 mg PO daily.

Official Title
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An Open-label Study to Assess the Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis With HCV Genotype 2 Infection

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: P1101 + Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥18 years of age (or other age required by local regulations); subjects who are over 70 years of age must be in generally good health. Confirmed diagnosis of chronic hepatitis with HCV genotype 2 infection. Compensated liver disease defined by normal or elevated alanine transaminase (ALT) ≤10 x upper limit of normal (ULN), total bilirubin level <2 mg/dL (except in Gilbert's syndrome), normal albumin, normal international normalized ratio (INR) Interferon treatment naïve: never received any interferon. No other known form of chronic liver disease apart from chronic hepatitis C infection. Hemoglobin 12 g/dL in men or 11 g/dL in women, white blood cell (WBC) count 3,000/mm3, absolute neutrophil count (ANC) 1,500/mm3, platelet count 90,000/mm3; and estimated glomerular filtration rate >60 mL/min. Female and male subjects, and their partners of reproductive potential using effective means of contraception during the whole trial period. Be able to attend all scheduled visits and to comply with all study procedures; Be able to provide written informed consent. Exclusion Criteria: Decompensated liver disease. Clinically significant illness or surgery within 4 weeks prior to dosing. Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study. Positive test for HBsAg or HIV at screening. Clinically significant abnormal vital signs. Evidence of severe retinopathy by fundoscopy except age-related macular degeneration. Significant alcohol or illicit drug abuse within one year prior to the screening visit or refusal to abstain from excessive alcohol consumption as defined above or illicit drugs throughout the study. Pregnant or breast feeding female subjects. Therapy with any systemic anti-viral, anti-neoplastic, and immunomodulatory treatment. Use of an investigational drug or participation in an investigational drug. Known clinically significant presence of any gastrointestinal pathology, clinically significant unresolved gastrointestinal symptoms, clinically significant liver or clinically significant kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug. Clinically significant presence of depression determined by investigators. Clinically significant presence of severe neurological disorders. Clinically significant presence of severe cardiovascular conditions and severe pulmonary conditions, uncontrolled immunologic, uncontrolled autoimmune, uncontrolled endocrine, uncontrolled metabolic, haematological, severe coagulation disorders or severe blood dyscrasias or other severe uncontrolled systemic disease. A depot injection or an implant of any drug within 3 months prior to administration of study medication, other than contraception or hyaluronic acid injections in joints for osteoarthritis; Body organ transplant and are taking immunosuppressants; History of malignant disease, including solid tumors and hematologic malignancies. However, subjects who are cancer survivors not on maintenance therapy and who had no malignant diseases history within the past 5 years could be recruited. History of or ongoing opportunistic infection. Serious local infection or systemic infection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P1101 + Ribavirin<br>P1101 400 µg SC Ribavirin 800-1400 mg PO | Drug: P1101 + Ribavirin<br>* P1101 400 µg SC<br>* Other names: Ropeginterferon alfa-2b;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of P1101 in the blood stream | The measurement of P1101 levels in the blood stream over time. The sampling time points are 0 hour before the first dose, 24±4 hours, 48±4 hours, 72±4 hours, 96±4 hours, 168±4 hours, 216±4 hours, 264±4 hours and 336±4 hours after first dose. PK sampling at 504±4 hours and 672±4 hours after first dose are optional. | 2-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | To evaluate the safety of P1101 by the proportion of adverse events | 2-4 weeks | 
| Abnormal Laboratory Assessments | To evaluate the safety of P1101 by the proportion of abnormal laboratory assessments | 2-4 weeks | 
| Positive anti-drug antibodies | To evaluate the positive anti-drug antibodies of P1101 by the proportion | 2-4 weeks | 
| Positive neutralizing antibody | To evaluate the positive neutralizing antibody of P1101 by the proportion | 2-4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, P1101, HCV genotype 2, PK, Hepatitis C, Chronic