Hepatitis C, ChronicPhase 1NCT04774107
The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection
A Phase 1 study testing P1101 + Ribavirin in people with Hepatitis C, Chronic, run by PharmaEssentia at 5 sites in Taiwan.
Trial summary
Primary Objective: To determine the P1101 pharmacokinetic (PK) profile at the single dose of 400 μg. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- P1101 + Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 5 sitesTaiwan
- Study dates
- 26 Nov 2020to 18 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Chang Gung Memorial Hospital, Chiayi Branch
Chiayi City
Chia-Yi Christian Hospital
Chiayi City
St. Martin De Porres Hospital
Chiayi City
Kaohsiung Medical University Hospital
Kaohsiung City
Chi Mei Medical Center
Tainan
About this study
Official title: 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.
Read the detailed description
Secondary Objective:
To determine the safety and immunogenicity of P1101 400 μg subcutaneous (SC) single dose + Ribavirin 800-1400 mg PO daily.
- Conditions
- Hepatitis C, Chronic
- Being tested
- P1101 + Ribavirin
- Keywords
- P1101, HCV genotype 2, Pharmacokinetics, PK, Hepatitis C, Chronic
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P1101 + RibavirinDrug
Also called Ropeginterferon alfa-2b
P1101 400 µg SC
| Study group | Role | What they receive |
|---|---|---|
| P1101 + Ribavirin | Experimental | P1101 400 µg SC Ribavirin 800-1400 mg PO Receives: Drug: P1101 + Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-4 weeks
Secondary outcomes (4)
Adverse Events
To evaluate the safety of P1101 by the proportion of adverse events
Measured: 2-4 weeks
Abnormal Laboratory Assessments
To evaluate the safety of P1101 by the proportion of abnormal laboratory assessments
Measured: 2-4 weeks
Positive anti-drug antibodies
To evaluate the positive anti-drug antibodies of P1101 by the proportion
Measured: 2-4 weeks
Positive neutralizing antibody
To evaluate the positive neutralizing antibody of P1101 by the proportion
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start26 Nov 2020
- Primary completion18 Jul 2022
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaEssentia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huang Yi-Wen, MD/PhD, Study director, PharmaEssentia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774107
- Sponsor's protocol ID
- A20-102
- Status last verified
- Aug 2022
- First submitted
- 21 Jan 2021
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Assess the Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis With HCV Genotype 2 Infection
- ClinicalTrials.gov ID
- NCT04774107
- Acronym / sponsor ID
- A20-102
- Conditions
- Hepatitis C, Chronic
- Keywords
- P1101, HCV genotype 2, Pharmacokinetics, PK, Hepatitis C, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- PharmaEssentiaIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To determine the P1101 pharmacokinetic (PK) profile at the single dose of 400 μg.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P1101 + Ribavirin | Experimental | Drug: P1101 + RibavirinP1101 400 µg SC Ribavirin 800-1400 mg PO |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P1101 + RibavirinAlso: Ropeginterferon alfa-2bP1101 400 µg SC | Drug | P1101 + Ribavirin |
Primary outcome
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.
4 secondary outcomes
Adverse Events
Time frame: 2-4 weeks
Abnormal Laboratory Assessments
Time frame: 2-4 weeks
Positive anti-drug antibodies
Time frame: 2-4 weeks
Positive neutralizing antibody
Time frame: 2-4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huang Yi-Wen, MD/PhD study director
PharmaEssentia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P1101 + Ribavirin in people with Hepatitis C, Chronic, run by PharmaEssentia at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of P1101 in the blood stream (time frame: 2-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.