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Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)

Sponsor
Symphogen A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00718692
Collaborator
Swedish Orphan Biovitrum (Industry)
61
Enrollment
59
Locations
1
Arm
39
Actual Duration (Months)
1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will receive a single IV dose of Sym001.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-centre, Single Intravenous Dose, Exploratory Dose-finding, Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP) in RhD Positive, Non-splenectomized Adult Subjects.
Actual Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Patients treated with Sym001

Drug: Sym001
Each cohort will receive one single dose of Sym001 according the assigned dose level.

Outcome Measures

Primary Outcome Measures

  1. Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs) [6 weeks post dosing]

Secondary Outcome Measures

  1. Measurements of platelet counts [From day 1 through week 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Confirmed presence of thrombocytopenia with platelet count < 30,000/mm3 at the pre-dose visit.

  • History of isolated ITP

  • RhD-positive serology.

  • Previous treatment and response to first line therapy for ITP

Exclusion Criteria:

  • Known clinical picture suggestive of other causes of thrombocytopenia, especially systematic lupus erythematosus,antiphospholipid syndrome, Evans syndrome, immunodeficiency states, lymphoproliferative disorders, liver disease,ingestion of drugs such as quinidine/quinine, heparin and sulfonamides and hereditary thrombocytopenia confirmed by relevant laboratory findings.

  • Suspected infection with HIV, Hepatitis C, H. pylori.

  • Clinical splenomegaly

  • History of abnormal bone marrow examination.

  • Ongoing haemorrhage corresponding to a grade 3 or 4 on the WHO bleeding scale.

  • Underlying haemolytic condition

  • History of splenectomy.

  • Subject is pregnant, breast feeding or intends to become pregnant.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Univ Nebraska Med Ctr. UNMC, 1005 Omaha Nebraska United States 68198-7680
2 Hospital of the University of Pennsylvania, Site 1002 Philadelphia Pennsylvania United States 19104
3 2085 Henry Tecklenburg Drive, 1001 Charleston South Carolina United States 29414
4 Research Site 3203 Brugge Belgium
5 Research Site 3202 Leuven Belgium
6 Research Site 3201 Yvoir Belgium
7 Research Site 4906, 4907 Berlin Germany
8 Research Site 4903 Duisburg Germany
9 Research Site 4905 Essen Germany
10 Reseach Site 4908 Halle Germany
11 Research Site 4901 Hannover Germany
12 Research Site 4902 Köln Germany
13 Research Site 4904 Regensburg Germany
14 St. John's Medical College Hospital, 9106 Bangalore India 560034
15 MS Ramaiah Memorial Hospital, 9108 Bangalore India 560054
16 Narayana Hrudayalaya Hospitals, 9105 Bangalore India 560099
17 Columbia Asia Referral Hospital-Yeshwanthpur, 9101 Bangalore India 576104
18 Aysha Hospital Pvt. Ltd., 9109 Chennai India 600010
19 Apollo Hospital, 9104 Hyderabad India 500033
20 Kasturba Medical College Hospital, 9103 Udupi India 576104
21 Bnai-Zion Medical Center, 9721 Haifa Israel 31048
22 Rambam Medical Center, 9723 Haifa Israel 35254
23 The Edith Wolfson Medical Center, 9725 Holon Israel 58100
24 Western Galilee - Nahariya Hospital, 9722 Nahariya Israel 22100
25 Rabin Medical Center, 9724 Petach Tikva Israel 49100
26 Tel-Aviv Sourasky Medical Center, 9726 Tel Aviv Israel 64239
27 Research site 4801 Gdansk Poland
28 Research Site 4806 Krakow Poland
29 Research Site 4805 Lodz Poland
30 Research Site 4803 Warszava Poland
31 Instytut Hematologii i Transfuzjologii, 4807 Warszawa Poland
32 Research Site 4802, 4808 Warszawa Poland
33 Research Site 4804 Wroclaw Poland
34 Brasov Country Hospital, 4002 Brasov Romania
35 Institutul Clinic Fundeni, 4003 Bucuresti Romania
36 "Prof. Dr. Ion Chiricuta" Oncolgy Institute, 4001 Cluj-Napoca Romania
37 Spitalul Clinic de Urgente Sfantu Spiridon, 4004 Iasi Romania
38 Regional Clinical Hospital of Nizhny Novgorod, 7003 Nizhny Novgorod Russian Federation 603126
39 Regional Clinical Hospital na MI Kalinin, 7005 Samara Russian Federation 443095
40 Saint Petersburg State Institution Of Healthcare, 7001 St. Petersburg Russian Federation 198205
41 State Healthcare Institution Tula Regional Clin. Hosp., 7002 Tula Russian Federation 300053
42 Clinical Center Nis 3802 Nis Serbia 18000
43 Clinical center Vojvodina 3801 Novi Sad Serbia 2100
44 Clinical Center Zemun 3803 Zemun Serbia 11080
45 Reseach Site 3403 Barcelona Spain
46 Hospital Gregorio Maranon, 3405 Madrid Spain
47 Hospital La Princesa, 3404 Madrid Spain
48 Research Site 3401 Madrid Spain
49 Research Site 3402 Valencia Spain
50 Cherkassy regional oncology center, 3906 Cherkassy Ukraine 180009
51 Gusak Academy of AMS Ukraine, 3905 Donetsk Ukraine 83045
52 Khmelnytskyi Regional Hospital, 3903 Khmelnytskyi Ukraine 29000
53 City Hospital #9 Kyiv Clinical Hospital, 3904 Kiev Ukraine 04112
54 Vinnytsya Regional Clinical Hospital, 3902 Vinnytsya Ukraine 21018
55 St. James's University Hospital, 4403 Leeds United Kingdom LS9 7TF
56 Hammersmith Hosptial, 4402 London United Kingdom W12 OHS
57 University College, 4401 London United Kingdom WC1E 6HX
58 Royal Victoria Infirmery, 4404 Newcastle Upon Tyne United Kingdom NE1 4LP
59 Singleton Hospital, 4405 Swansea United Kingdom SA2 8QL

Sponsors and Collaborators

  • Symphogen A/S
  • Swedish Orphan Biovitrum

Investigators

  • Principal Investigator: Mario Von Depka Prondzinski, PD Dr., Werlhoff Institut Hannover, Germany
  • Principal Investigator: Ann Janssens, Dr., ZU Gasthuisberg, Leuven, Belgium
  • Principal Investigator: Javier Loscertales Pueyo, Dra, Hospital La Princesa, Madrid, Spain
  • Principal Investigator: Wieslaw Wiktor Jedrzrjczak, Prof., Katedra i klinika Hematologii, Warszawa, Poland
  • Principal Investigator: Andrei Cucucianu, Dr., Prof. Dr. Ion Chiricuta Oncology Institute, Cluj-Napoca, Romania
  • Principal Investigator: Marie Scully, Prof. Dr. MD, University College London Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Symphogen A/S
ClinicalTrials.gov Identifier:
NCT00718692
Other Study ID Numbers:
  • Sym001-03
  • 2007-006081-15
First Posted:
Jul 21, 2008
Last Update Posted:
Jan 30, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Symphogen A/S
Idiopathic
ITP
Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic

Study Results

No Results Posted as of Jan 30, 2019