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21 March 2013
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| [ Print-friendly version ] |
| Clinical study to evaluate the efficacy and safety of immunoglobulin intravenous (human) 10% (NewGam) in Primary Immune Thrombocytopenia |
| ISRCTN | ISRCTN37539930 |
| DOI | 10.1186/ISRCTN37539930 |
| ClinicalTrials.gov identifier | NCT01349790 |
| EudraCT number | |
| Public title | Clinical study to evaluate the efficacy and safety of immunoglobulin intravenous (human) 10% (NewGam) in Primary Immune Thrombocytopenia |
| Scientific title | Prospective, open-label, non-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of immunoglobulin intravenous (human) 10% (NewGam) in Primary Immune Thrombocytopenia |
| Acronym | N/A |
| Serial number at source | NGAM-02 |
| Study hypothesis | To assess the efficacy of NewGam in correcting the platelet count. |
| Lay summary |
Background and study aims
In this study, it will be assessed, whether NewGam [immunoglobulin intravenous (human)] corrects (i.e. increases) the platelet count. Who can participate? Patients with confirmed diagnosis of chronic Primary Immune Thrombocytopenia (ITP) of at least 12 months duration, age >=18 years and <=65 years, and a platelet count of <20x10 exp9/L with or without bleeding manifestations. What does the study involve? Beside examination at study start all patients will receive two intravenous infusions of NewGam at two consecutive days. Over a period of 63 days participants will be asked to give a small amount of blood for assessment of platelet count and safety parameters. What are the possible benefits and risks of participating? Patient will receive NewGam for a quick increase in platelet count. During this study the patients’ health condition will be assessed in shorter intervals than normal. The most common side effects when people take intravenous (IV) immunoglobulin are headache, chills, back pain, chest pain, myalgia, fever, cutaneous reactions, fatigue, various minor allergic and hypersensitivity type of reactions, hot flushes and nausea. Where is the study run from? The study has been set up by Octapharma AG, a pharmaceutical company. When is study starting and how long is it expected to run for? Study started in June 2011 and expected to end in June 2013. Who is funding the study? Octapharma AG (Switzerland) Who is the main contact? Birgit Taumberger Birgit.taumberger@octapharma.com |
| Ethics approval |
1. Ethics Committee of the Institute for Clinical and Experimental Medicine and Thomayer Hospital, Prague, Czech Republic, 11.05.2011, ref: 710/11 (M11-25)
2. Ethics Committee for Multicentre Trials, 8 Damyan Gruev Str., 1303 Sofia, Bulgaria, 3.10.2011, KE-107/22.06.2011 3. Comité de Protection des personnes Sud Méditérrannée I, Institut Paoli Calmettes, 232 Boulevard Ste Marguerite, 13009 Marseille; France; 30. 01. 2012, Ref: 11 47 4. Ethik-Kommission des Landes Berlin Landesamt für Gesundheit und Soziales Berlin, Fehrbelliner Platz 1, 10707 Berlin; 07.09. 2011, 11/0218 ZS EK 5. Independent Bioethical Committee for Scientific Research at Medical University in Gdañsk, 3a M. Sk³odowskiej - Curie str.; 80-210 Gdañsk, 07.07.2011 6. National Ethics Committee, 48 Av. Sanatescu St., District 1, Bucharest, Romania, 20.07.2011 7. Ministry of Healthcare and Social Development, Ethics Committee, 8, Petrovskiy avenue,127051, Moscow, Russia, 24.08.2011 8. Central Ethics Commitee, 03680 Kiev, st. Narodnogo Opolchenia, 5, Ukraine, 5.12-1035/KE, 07.09.2011 9. lnstitutional Ethics committee for Sahyadri Hospitals, 30C, Erandawane, Karve Road, Pune 411004, India, 18.08.2011 |
| Study design | Prospective open-label non-controlled multicenter phase III clinical study |
| Countries of recruitment | Bulgaria, Czech Republic, France, Germany, India, Poland, Romania, Russian Federation, Ukraine |
| Disease/condition/study domain | Primary Immune Thrombocytopenia (ITP) |
| Participants - inclusion criteria |
1. Age of >=18 years years and <=65 years
2. Confirmed diagnosis of chronic primary ITP of at least 12 months duration (diagnosed with threshold platelet count less than 100x109/L) 3. Platelet count of <=20x10exp9/L with or without bleeding manifestations |
| Participants - exclusion criteria |
1. Thrombocytopenia secondary to other diseases (such as Acquired Immunodeficiency Syndrome [AIDS] or systemic lupus erythematosus [SLE]) or drug-related thrombocytopenia.
2. Administration of intravenous immunoglobulin (IGIV), anti-D or thrombopoetin receptor agonists or other platelet enhancing drugs (incl. immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrollment 3. Unresponsive to previous treatment with IGIV or anti-D immunoglobulin. 4. Severe liver or kidney disease (alanine aminotransferase [ALAT] 3x > upper limit of normal, creatinine >120 µmol/L). 5. Patients with risk factors for thromboembolic events in whom the risks outweigh the potential benefit of NewGam treatment. |
| Anticipated start date | 30/06/2011 |
| Anticipated end date | 30/06/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 95 |
| Interventions | All patients will receive 1 g/kg/day NewGam by intravenous infusion for 2 consecutive days, for a total of 2 g/kg. |
| Primary outcome measure(s) | The primary efficacy measure is defined as an increase in platelets to atleast 50x109/L within 7 days after the first infusion, i.e. by study Day 8 (at least once prior to Day 9). |
| Secondary outcome measure(s) | Additional response rates will be calculated on basis of an alternative definition for response and for additionally defined criteria for complete response and loss of response. |
| Sources of funding | Octapharma AG (Switzerland) |
| Trial website | |
| Publications | |
| Contact name | Prof Abdulgabar Salama |
| Address |
Universitätsklinikum Charité
Med. Fakultät der Humboldt-Universität zu Berlin Institut für Transfusionsmedizin Campus Virchow-Klinikum Augustenburger Platz 1 |
| City/town | Berlin |
| Zip/Postcode | 13353 |
| Country | Germany |
| Sponsor | Octapharma AG (Switzerland) |
| Address | Seidenstrasse 2 |
| City/town | Lachen |
| Zip/Postcode | CH-8853 |
| Country | Switzerland |
| Sponsor website: | http://www.octapharma.com |
| Date applied | 20/02/2013 |
| Last edited | 27/02/2013 |
| Date ISRCTN assigned | 27/02/2013 |
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