Chronic Hepatitis C Virus Genotype IPhase 1/2NCT02057887
Safety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A)
A Phase 1/2 study testing HM10660A and Pegasys in people with Chronic Hepatitis C Virus Genotype I, run by Hanmi Pharmaceutical Company Limited at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of HM10660A in subjects with chronic hepatitis C(HCV). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C Virus Genotype I
- What is being tested?
- HM10660A and Pegasys
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2013to Aug 2014
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 65 years old, inclusive
- Willing and able to provide written informed consent.
- Previously untreated HCV infection with HCV RNA > 75,000 IU/mL at screening.
- HCV genotype 1a or 1b.
- Body mass index (BMI) between 18 and 38 kg/m2.
- Willing and able to comply with the protocol and available to complete the study schedule of assessments.
Who cannot join
- Pregnant women or women who may wish to become pregnant during the course of the study.
- Males and females of reproductive potential who are unwilling to use 2 forms of effective birth control throughout the duration of study treatment and for at least 6 months after the last dose of RBV. One method should include a condom with spermicide for males. Males must agree to refrain from sperm donation for at least 6 months after the last dose of RBV.
- Evidence of infection or co-infection with a non-genotype 1 HCV strain.
- Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
- Lactating females
Trial locations and contacts
1 site in 1 country.
Hanmi Clinical contact
Mexico1 site, 1 recruiting
- Recruiting
Hanmi Clinical
Estado de México, State of Mexico
Hanmi Clinical, clinical4@hanmi.co.kr
About this study
The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of HM10660A in subjects with chronic hepatitis C(HCV).
Read the detailed description
- To evaluate the repeat-dose pharmacokinetics (PK) of HM10660A when given by weekly, biweekly, and monthly subcutaneous (SC) injection.
- To evaluate the repeat-dose pharmacodynamics (PD) of HM10660A when given by weekly, biweekly, and monthly SC injection.
- To explore the antiviral activity of HM10660A at Week 4, Week 12, and Week 24.
- Conditions
- Chronic Hepatitis C Virus Genotype I
- Being tested
- HM10660A, Pegasys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM10660ADrug
Also called Laps-IFNa
PegasysDrug
180 mcg Pegasys SC once weekly
| Study group | Role | What they receive |
|---|---|---|
| Cohort1 | Experimental | HM10660A SC once weekly Receives: Drug: HM10660A |
| Cohort2 | Experimental | HM10660A SC once every 2 weeks Receives: Drug: HM10660A |
| Cohort3 | Experimental | HM10660A SC once every 4 weeks Receives: Drug: HM10660A |
| Cohort4 | Active comparator | 180 mcg Pegasys SC once weekly Receives: Drug: Pegasys |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV RNA Viral load
Measured: Through study week 32
Safety/tolerability
symptom-directed physical examination, Vital signs, Inspection of the Injection site, Complete Physical examination, 12-lead ECG, Hematology/coagulation
Measured: Through study week 32
Secondary outcomes (3)
Rapid virologic response (RVR)
Measured: Study Week 4
Early virologic response (EVR)
Measured: Study week 12
Sustained virologic response (SVR)
Measured: Study week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C Virus Genotype IStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057887
- Sponsor's protocol ID
- HM-IFN-201
- Status last verified
- Feb 2014
- First submitted
- 8 Aug 2013
- Last updated
- 7 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A)
- ClinicalTrials.gov ID
- NCT02057887
- Acronym / sponsor ID
- HM-IFN-201
- Conditions
- Chronic Hepatitis C Virus Genotype I
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (estimated)
- First posted
- 7 Feb 2014 (estimated)
- 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.
The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of HM10660A in subjects with chronic hepatitis C(HCV).
Detailed description
- To evaluate the repeat-dose pharmacokinetics (PK) of HM10660A when given by weekly, biweekly, and monthly subcutaneous (SC) injection.
- To evaluate the repeat-dose pharmacodynamics (PD) of HM10660A when given by weekly, biweekly, and monthly SC injection.
- To explore the antiviral activity of HM10660A at Week 4, Week 12, and Week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort1 | Experimental | Drug: HM10660AHM10660A SC once weekly |
| Cohort2 | Experimental | Drug: HM10660AHM10660A SC once every 2 weeks |
| Cohort3 | Experimental | Drug: HM10660AHM10660A SC once every 4 weeks |
| Cohort4 | Active comparator | Drug: Pegasys180 mcg Pegasys SC once weekly |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, aged 18 to 65 years old, inclusive
- Willing and able to provide written informed consent.
- Previously untreated HCV infection with HCV RNA > 75,000 IU/mL at screening.
- HCV genotype 1a or 1b.
- Body mass index (BMI) between 18 and 38 kg/m2.
Key exclusion criteria (5 listed)
- Pregnant women or women who may wish to become pregnant during the course of the study.
- Males and females of reproductive potential who are unwilling to use 2 forms of effective birth control throughout the duration of study treatment and for at least 6 months after the last dose of RBV. One method should include a condom with spermicide for males. Males must agree to refrain from sperm donation for at least 6 months after the last dose of RBV.
- Evidence of infection or co-infection with a non-genotype 1 HCV strain.
- Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
- Lactating females
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 |
|---|---|---|
| HM10660AAlso: Laps-IFNa | Drug | Cohort1, Cohort2, Cohort3 |
| Pegasys180 mcg Pegasys SC once weekly | Drug | Cohort4 |
Primary outcome
HCV RNA Viral load
Time frame: Through study week 32
Safety/tolerability
Time frame: Through study week 32
symptom-directed physical examination, Vital signs, Inspection of the Injection site, Complete Physical examination, 12-lead ECG, Hematology/coagulation
3 secondary outcomes
Rapid virologic response (RVR)
Time frame: Study Week 4
Early virologic response (EVR)
Time frame: Study week 12
Sustained virologic response (SVR)
Time frame: Study week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
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.
Hanmi Clinical contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HM10660A and Pegasys in people with Chronic Hepatitis C Virus Genotype I, run by Hanmi Pharmaceutical Company Limited at 1 site in Mexico.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanmi Clinical (clinical4@hanmi.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV RNA Viral load (time frame: Through study week 32). The study lists 2 primary outcomes in all. 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 7 Feb 2014.