Hepatitis C, ChronicPhase 1NCT01337375
A Study of the Pharmacokinetics And Pharmacodynamics of Intravenously Administered Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C And Previous Non-Response to Pegylated Interferon And Ribavirin Combination Therapy
A Phase 1 study testing peginterferon alfa 2a [Pegasys] and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 5 sites in Germany.
Trial summary
In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with viral load and viral kinetics will be investigated in patients with chronic hepatitis C genotype 1 who were non-responders to previous… 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?
- peginterferon alfa 2a [Pegasys] and peginterferon alfa-2a [Pegasys]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 5 sitesGermany
- Study dates
- Mar 2011to Apr 2012
- 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
- Adult caucasian patients, 18 - 70 years of age
- Hepatitis C, genotype 1
- Non-responder to previous anti-HCV therapy with peginterferon alfa and ribavirin
- Compensated liver disease (Child-Pugh class A) for >/= 24 months before baseline
- Positive for anti-HCV for > 6 months, with detectable serum HCV-RNA
Who cannot join
- Treatment-naïve or responder to previous therapy
- HCV infection other than genotype 1
- Positive for Hepatitis A, Hepatitis B or HIV infection at screening
- Chronic Hepatitis of other than HCV origin
- Decompensated liver disease (Child-Pugh class B or C)
- Therapy with systemic antiviral, antineoplastic or immunomodulatory agents in the 6 months prior to study
- Clinically relevant retina disorder
- Pregnant or lactating women and male partners of pregnant women
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Study site
Berlin, 10969
Study site
Frankfurt am Main, 60590
Study site
Hamburg, 20099
Study site
Hanover, 30625
Study site
Leipzig, 04103
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Intravenous Administration of Pegylated Interferon-2a in Patients With Chronic Hepatitis C and Previous Non-response to Standard Combination Therapy With Pegylated Interferon and Ribavirin (Intervention Study)
In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with viral load and viral kinetics will be investigated in patients with chronic hepatitis C genotype 1 who were non-responders to previous standard combination therapy with pegylated interferon and ribavirin. Patients will be randomized to receive either weekly or twice weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after a washout period of 6 weeks.
- Conditions
- Hepatitis C, Chronic
- Being tested
- peginterferon alfa 2a [Pegasys], peginterferon alfa-2a [Pegasys]
- 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.
peginterferon alfa 2a [Pegasys]Drug
sc weekly
peginterferon alfa-2a [Pegasys]Drug
iv weekly
peginterferon alfa-2a [Pegasys]Drug
sc twice weekly
peginterferon alfa-2a [Pegasys]Drug
iv twice weekly
| Study group | Role | What they receive |
|---|---|---|
| A/B | Experimental | Not described Receives: Drug: peginterferon alfa 2a [Pegasys]; Drug: peginterferon alfa-2a [Pegasys] |
| C/D | Experimental | Not described Receives: Drug: peginterferon alfa-2a [Pegasys] |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV RNA levels (IU/ml, COBAS TaqMan HCV Test) in correlation with area under the plasma concentration-time curve (AUC) after sc and iv administration
Measured: 11 months
Secondary outcomes (4)
Evaluation of predictors of response to i.v. treatment
Measured: 11 months
Effect of waist to hip ratio on pharmacokinetics
Measured: 11 months
Effect of waist to hip ratio on viral response
Measured: 11 months
Incidence of adverse events
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2012
- Study completionApr 2012
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.
- More trials run by Hoffmann-La RocheThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337375
- Sponsor's protocol ID
- ML22936
- Status last verified
- Nov 2016
- First submitted
- 29 Mar 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Intravenous Administration of Pegylated Interferon-2a in Patients With Chronic Hepatitis C and Previous Non-response to Standard Combination Therapy With Pegylated Interferon and Ribavirin (Intervention Study)
- ClinicalTrials.gov ID
- NCT01337375
- Acronym / sponsor ID
- ML22936
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Apr 2011 (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.
In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with viral load and viral kinetics will be investigated in patients with chronic hepatitis C genotype 1 who were non-responders to previous standard combination therapy with pegylated interferon and ribavirin. Patients will be randomized to receive either weekly or twice weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after a washout period of 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A/B | Experimental | Drug: peginterferon alfa 2a [Pegasys], Drug: peginterferon alfa-2a [Pegasys] |
| C/D | Experimental | Drug: peginterferon alfa-2a [Pegasys] |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult caucasian patients, 18 - 70 years of age
- Hepatitis C, genotype 1
- Non-responder to previous anti-HCV therapy with peginterferon alfa and ribavirin
- Compensated liver disease (Child-Pugh class A) for >/= 24 months before baseline
- Positive for anti-HCV for > 6 months, with detectable serum HCV-RNA
Key exclusion criteria (8 listed)
- Treatment-naïve or responder to previous therapy
- HCV infection other than genotype 1
- Positive for Hepatitis A, Hepatitis B or HIV infection at screening
- Chronic Hepatitis of other than HCV origin
- Decompensated liver disease (Child-Pugh class B or C)
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 |
|---|---|---|
| peginterferon alfa 2a [Pegasys]sc weekly | Drug | A/B |
| peginterferon alfa-2a [Pegasys]iv weekly | Drug | A/B |
| peginterferon alfa-2a [Pegasys]sc twice weekly | Drug | C/D |
| peginterferon alfa-2a [Pegasys]iv twice weekly | Drug | C/D |
Primary outcome
HCV RNA levels (IU/ml, COBAS TaqMan HCV Test) in correlation with area under the plasma concentration-time curve (AUC) after sc and iv administration
Time frame: 11 months
4 secondary outcomes
Evaluation of predictors of response to i.v. treatment
Time frame: 11 months
Effect of waist to hip ratio on pharmacokinetics
Time frame: 11 months
Effect of waist to hip ratio on viral response
Time frame: 11 months
Incidence of adverse events
Time frame: 11 months
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 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
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 peginterferon alfa 2a [Pegasys] and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 5 sites in Germany.
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 5 inclusion and 8 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 2 Nov 2016. 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 Germany. 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?
HCV RNA levels (IU/ml, COBAS TaqMan HCV Test) in correlation with area under the plasma concentration-time curve (AUC) after sc and iv administration (time frame: 11 months). 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 2 Nov 2016.