- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04774107
The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection
August 25, 2022 updated by: PharmaEssentia
An Open-label Study to Assess the Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis With HCV Genotype 2 Infection
Primary Objective:
To determine the P1101 pharmacokinetic (PK) profile at the single dose of 400 μg.
Study Overview
Detailed Description
Secondary Objective:
To determine the safety and immunogenicity of P1101 400 μg subcutaneous (SC) single dose + Ribavirin 800-1400 mg PO daily.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Chiayi City, Taiwan
- Chia-Yi Christian Hospital
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Chiayi City, Taiwan
- Chang Gung Memorial Hospital, Chiayi Branch
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Chiayi City, Taiwan
- St. Martin De Porres Hospital
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Kaohsiung, Taiwan
- Kaohsiung Medical University Hospital
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Tainan City, Taiwan
- Chi Mei Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: P1101 + Ribavirin
P1101 400 µg SC Ribavirin 800-1400 mg PO
|
P1101 400 µg SC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of P1101 in the blood stream
Time Frame: 2-4 weeks
|
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
Time Frame: 2-4 weeks
|
To evaluate the safety of P1101 by the proportion of adverse events
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2-4 weeks
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Abnormal Laboratory Assessments
Time Frame: 2-4 weeks
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To evaluate the safety of P1101 by the proportion of abnormal laboratory assessments
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2-4 weeks
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Positive anti-drug antibodies
Time Frame: 2-4 weeks
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To evaluate the positive anti-drug antibodies of P1101 by the proportion
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2-4 weeks
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Positive neutralizing antibody
Time Frame: 2-4 weeks
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To evaluate the positive neutralizing antibody of P1101 by the proportion
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2-4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Huang Yi-Wen, MD/PhD, PharmaEssentia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 26, 2020
Primary Completion (Actual)
July 18, 2022
Study Completion (Actual)
July 18, 2022
Study Registration Dates
First Submitted
January 21, 2021
First Submitted That Met QC Criteria
February 25, 2021
First Posted (Actual)
March 1, 2021
Study Record Updates
Last Update Posted (Actual)
August 30, 2022
Last Update Submitted That Met QC Criteria
August 25, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
Other Study ID Numbers
- A20-102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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