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

NCT04774107 | Completed Phase 1

• 1 other identifier: A20-102
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Hepatitis C, Chronic

Keywords

P1101; HCV genotype 2; Pharmacokinetics; PK; Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adverse Events

  2-4 weeks

• Abnormal Laboratory Assessments

  2-4 weeks

• Positive anti-drug antibodies

  2-4 weeks

• Positive neutralizing antibody

  2-4 weeks

Study Arms (1)

P1101 + Ribavirin

EXPERIMENTAL

P1101 400 µg SC Ribavirin 800-1400 mg PO

Drug: P1101 + Ribavirin

Interventions

P1101 + Ribavirin DRUG

P1101 400 µg SC

Also known as: Ropeginterferon alfa-2b

P1101 + Ribavirin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• PharmaEssentia: lead

Study Sites (5)

Chang Gung Memorial Hospital, Chiayi Branch

Chiayi City, Taiwan

Location

Chia-Yi Christian Hospital

Chiayi City, Taiwan

Location

St. Martin De Porres Hospital

Chiayi City, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Location

Chi Mei Medical Center

Tainan, Taiwan

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Huang Yi-Wen, MD/PhD

  PharmaEssentia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: March 1, 2021
• Study Start: November 26, 2020
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

TW (5)