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Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera (PEGINVERA)

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ClinicalTrials.gov Identifier: NCT01193699
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : January 30, 2018
Information provided by (Responsible Party):
AOP Orphan Pharmaceuticals AG

September 1, 2010
September 2, 2010
January 30, 2018
August 2010
January 25, 2018   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01193699 on ClinicalTrials.gov Archive Site
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Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera
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
The purpose of this study is the identification of the maximum tolerated dose (MTD) of the investigational medicinal product. Moreover the safety and tolerability will be assessed and an exploratory analysis of efficacy and biomarker modulation will be performed.
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Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Polycythemia Vera
Drug: PEG-P-INF alpha-2b (P1101)
µg (starting with 50 µg), subcutaneously, 2-weekly administration
Experimental: P1101
Intervention: Drug: PEG-P-INF alpha-2b (P1101)
Gisslinger H, Zagrijtschuk O, Buxhofer-Ausch V, Thaler J, Schloegl E, Gastl GA, Wolf D, Kralovics R, Gisslinger B, Strecker K, Egle A, Melchardt T, Burgstaller S, Willenbacher E, Schalling M, Them NC, Kadlecova P, Klade C, Greil R. Ropeginterferon alfa-2b, a novel IFNα-2b, induces high response rates with low toxicity in patients with polycythemia vera. Blood. 2015 Oct 8;126(15):1762-9. doi: 10.1182/blood-2015-04-637280. Epub 2015 Aug 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 25, 2018
January 25, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Written informed consent obtained prior to any study specific screening activities and able to comply with this protocol.
  2. Patients age ≥18 years
  3. 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.
  4. Eastern Cooperative Oncology Group performance status ≤ 2
  5. 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.

Exclusion criteria:

  1. Diagnosis of any other myeloproliferative disorder
  2. Any clinically significant illness or surgery within 4 weeks prior to dosing
  3. Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
  4. 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.
  5. Previous treatment with Interferon for PV
  6. Concurrent treatment with cytoreductive agents other than Hydroxyurea and investigational agents of any type
  7. 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
  8. History of severe allergic (like anaphylaxis) or hypersensitivity reactions (like angioedema), any known or suspected intolerance to the investigational product.
  9. Use of any investigational drug or participation in any investigational drug study within the last 4 weeks
  10. Clinically significant history or known presence of psychiatric disorders, including but not limited to depression, anxiety and sleep disorders
  11. Organ transplant, past or planned
  12. Inadequate liver function defined by serum (total) bilirubin > 2,5 x ULN and/ or AST and ALT > 2,5 x ULN
  13. Clinically significant ECG findings
  14. History of renal disease requiring haemodialysis or seizure disorder requiring anticonvulsant therapy
  15. Pregnant or lactating females (pregnancy test to be assessed within 7 days prior to study treatment start)
  16. Acute or chronic infections or autoimmune diseases (collagen diseases, polyarthritis, immune thrombocythemia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder).
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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AOP Orphan Pharmaceuticals AG
AOP Orphan Pharmaceuticals AG
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Study Director: Barbara Grohmann-Izay, MD AOP Orphan Pharmaceuticals AG
AOP Orphan Pharmaceuticals AG
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP