Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera (PEGINVERA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01193699|
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : January 30, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Polycythemia Vera||Drug: PEG-P-INF alpha-2b (P1101)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Prospective, Multicentre, Phase I/II Dose Escalation Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Efficacy of P1101, PEG-Proline-Interferon Alpha-2b in Patients With Polycythaemia Vera|
|Actual Study Start Date :||August 2010|
|Actual Primary Completion Date :||January 25, 2018|
|Actual Study Completion Date :||January 25, 2018|
Drug: PEG-P-INF alpha-2b (P1101)
µg (starting with 50 µg), subcutaneously, 2-weekly administration
- Maximum tolerated dose (MTD) [ Time Frame: The incidence of dose limiting toxicities (DLTs), which define the MTD are assessed continously until achievement of MTD. ]The definition of MTD is based on a 3+3 dose escalation design. MTD is defined as the next lower dose of that dose which was considered to be untolerated (observed DLT frequency at least 2 out of 3 in one cohort or at least 2 out of six patients in 2 cohorts).
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|Ages Eligible for Study:||18 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Written informed consent obtained prior to any study specific screening activities and able to comply with this protocol.
- Patients age ≥18 years
- Confirmed diagnosis of PV according to either the WHO criteria (2008, appendix 6) or the PSVG (appendix 7) criteria plus JAK-2 positivity, including newly diagnosed, pre-treated and on cytoreductive therapy.
- Eastern Cooperative Oncology Group performance status ≤ 2
- If female of childbearing potential - have a negative urine pregnancy test result within 7 days prior to the scheduled first application of investigational product and agree to employ adequate birth control measures for the duration of the study.
- Diagnosis of any other myeloproliferative disorder
- Any clinically significant illness or surgery within 4 weeks prior to dosing
- Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
- Uncontrolled hypertension (systolic > 150 mmHg and diastolic > 100 mmHg, or clinically significant (i.e. active) cardiovascular disease: CVA/stroke (≤ 3 months prior to enrolment), myocardial infarction (≤ 3 months prior to enrolment), significant coronary artery stenosis, unstable angina, New York Heart Association (NYHA) Class 2 or greater Congestive heart failure, or serious cardiac arrhythmia requiring medication.
- Previous treatment with Interferon for PV
- Concurrent treatment with cytoreductive agents other than Hydroxyurea and investigational agents of any type
- History of malignant disease, including solid tumours and haematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that have been completely excised and are considered cured) within the last 3 years
- History of severe allergic (like anaphylaxis) or hypersensitivity reactions (like angioedema), any known or suspected intolerance to the investigational product.
- Use of any investigational drug or participation in any investigational drug study within the last 4 weeks
- Clinically significant history or known presence of psychiatric disorders, including but not limited to depression, anxiety and sleep disorders
- Organ transplant, past or planned
- Inadequate liver function defined by serum (total) bilirubin > 2,5 x ULN and/ or AST and ALT > 2,5 x ULN
- Clinically significant ECG findings
- History of renal disease requiring haemodialysis or seizure disorder requiring anticonvulsant therapy
- Pregnant or lactating females (pregnancy test to be assessed within 7 days prior to study treatment start)
- Acute or chronic infections or autoimmune diseases (collagen diseases, polyarthritis, immune thrombocythemia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193699
|Innsbruck, Tirol, Austria, 6020|
|Wels, Upper Austria, Austria, 4600|
|Salzburg, Austria, 5020|
|Vienna, Austria, 1090|
|Vienna, Austria, 1140|
|Vienna, Austria, 1220|
|Study Director:||Barbara Grohmann-Izay, MD||AOP Orphan Pharmaceuticals AG|
|Responsible Party:||AOP Orphan Pharmaceuticals AG|
|Other Study ID Numbers:||
|First Posted:||September 2, 2010 Key Record Dates|
|Last Update Posted:||January 30, 2018|
|Last Verified:||January 2018|
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