AnemiaPhase 4NCT00560274
A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C.
A Phase 4 study testing Pegasys, Ribavirin and epoetin beta [NeoRecormon] in people with Anemia, run by Hoffmann-La Roche at 24 sites in France.
Trial summary
This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Pegasys, Ribavirin and epoetin beta [NeoRecormon]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 24 sitesFrance
- Study dates
- Mar 2008to Nov 2011
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, >=18 years of age;
- chronic hepatitis C;
- quantifiable serum HCV RNA;
- Pegylated interferon + ribavirin treatment started <6 months before study;
- Hb <10g/dL.
Who cannot join
- treatment with ESA during preceding 12 weeks;
- poorly controlled hypertension;
- history of cancer, except for basal cell cancer and cervical cancer in situ.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
Study site
Angers, 49933
Study site
Besançon, 25030
Study site
Caen, 14033
Study site
Chambray-lès-Tours, 37171
Study site
Clichy, 92118
Study site
Créteil, 94000
Study site
Créteil, 94010
Study site
Limoges, 87042
Study site
Lyon, 69437
Study site
Marseille, 13285
Study site
Marseille, 13385
Study site
Montpellier, 34295
Study site
Nice, 06202
Study site
Paris, 75571
Study site
Paris, 75651
Study site
Pessac, 33604
Study site
Rennes, 35033
Study site
Rouen, 76031
Study site
Saint-Laurent-du-Var, 06721
Study site
Strasbourg, 67091
Study site
Toulouse, 31059
Study site
Tourcoing, 59208
Study site
Vandœuvre-lès-Nancy, 54511
Study site
Villejuif, 94804
About this study
Official title: An Open Label Study to Evaluate the Safety of NeoRecormon in the Treatment of Anemia in Patients With Chronic Hepatitis C Who Are Treated With Pegylated Interferon + Ribavirin Combination Therapy
This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegasysDrug
As prescribed
RibavirinDrug
As prescribed
epoetin beta [NeoRecormon]Drug
30,000 IU sc/week (starting dose)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Pegasys; Drug: Ribavirin; Drug: epoetin beta [NeoRecormon] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure, pulse rate.
Measured: 6 and 12 months
AEs, and laboratory parameters.
Measured: Throughout study
Secondary outcomes (4)
Percentage of patients achieving correction of anemia
Measured: 3 months
Percentage of patients not requiring blood transfusion
Measured: 12 months
Course of Hb concentration
Measured: 12 months
Percentage of patients maintaining initial ribavirin dose
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startMar 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 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
- NCT00560274
- Sponsor's protocol ID
- ML21362
- Status last verified
- Feb 2016
- First submitted
- 16 Nov 2007
- Last updated
- 2 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Safety of NeoRecormon in the Treatment of Anemia in Patients With Chronic Hepatitis C Who Are Treated With Pegylated Interferon + Ribavirin Combination Therapy
- ClinicalTrials.gov ID
- NCT00560274
- Acronym / sponsor ID
- ML21362
- Conditions
- Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 19 Nov 2007 (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.
This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pegasys, Drug: Ribavirin, Drug: epoetin beta [NeoRecormon] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients, >=18 years of age;
- chronic hepatitis C;
- quantifiable serum HCV RNA;
- Pegylated interferon + ribavirin treatment started <6 months before study;
- Hb <10g/dL.
Key exclusion criteria (3 listed)
- treatment with ESA during preceding 12 weeks;
- poorly controlled hypertension;
- history of cancer, except for basal cell cancer and cervical cancer in situ.
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 |
|---|---|---|
| PegasysAs prescribed | Drug | 1 |
| RibavirinAs prescribed | Drug | 1 |
| epoetin beta [NeoRecormon]30,000 IU sc/week (starting dose) | Drug | 1 |
Primary outcome
Blood pressure, pulse rate.
Time frame: 6 and 12 months
AEs, and laboratory parameters.
Time frame: Throughout study
4 secondary outcomes
Percentage of patients achieving correction of anemia
Time frame: 3 months
Percentage of patients not requiring blood transfusion
Time frame: 12 months
Course of Hb concentration
Time frame: 12 months
Percentage of patients maintaining initial ribavirin dose
Time frame: 12 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 Feb 2016.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegasys, Ribavirin and epoetin beta [NeoRecormon] in people with Anemia, run by Hoffmann-La Roche at 24 sites in France.
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 3 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Blood pressure, pulse rate. (time frame: 6 and 12 months). 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 2 Feb 2016.