Aktuelle Studien Abteilung Klinische Pharmakologie
Im Heidelberger Klinisch-Pharmakologischen Studienzentrum wird ein breites Spektrum von gesunden Probanden:innen bis hin zu schwer erkrankten Patient:innen betreut. Wir führen sowohl eigeninitiierte, als auch industriegesponserte Studien, vornehmlich der frühen Phasen, durch.
- Sie interessieren sich für eine Studienteilnahme als gesunder Freiwilliger? Hier finden Sie relevante Informationen.
- Sie sind Patient und sollen in unserem Klinisch-Pharmakologischen Studienzentrum behandelt werden? Erste Informationen erhalten Sie hier.
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Studienteilnehmer:innen gesucht!
Eine Übersicht der Studien, für die wir aktuell (gesunde) Studienteilnehmer:innen suchen, finden Sie hier.
Kooperationsstudien am Universitätsklinikum Heidelberg
Des Weiteren werden auch Studien in Kooperation mit anderen Fachabteilungen und Partnern am Universitätsklinikum Heidelberg durchgeführt.
Hierzu gehören unter anderem:
- Hämato-onkologische Studien (Phase I-III Studien mit Fokus auf Multiplem Myelom),
- onkologische Studien zu vielen weiteren Tumorentitäten (NCT)
- Studien mit gastroenterologischer Indikation
- Studien mit kardiologischer Indikation
Studien mit pädiatrischen Patienten oder vornehmlich pneumologischer Indikation (u. a. auch Studien nach dem Medizinproduktegesetz) werden bei unseren Netzwerk-Partnern, dem pädiatrischen klinisch-pharmakologischen-Studienzentrum (paedKliPS) und dem pneumologischen klinisch-pharmakologischen Studienzentrum (ThoraxKliPS) durchgeführt.
Laufende Studien
Im Folgenden finden Sie eine Übersicht aller aktuell laufenden Studien, die Sie auch hier als pdf herunterladen können.
| EudraCT - NUMMER | KURZTITEL | DESIGN |
|---|---|---|
| 2017-000785-29 | DOAK - Geriatrie | Pharmacokinetics of microdose rivaroxaban, apixaban and edoxaban in geriatric patients |
| 2015-002971-12 | IMCgp100-201 | A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 in combination with Durvalumab (MEDI4736) or Tremelimumab or the combiantion of Durvalumab and Tremelimumab compared to IMCgp100 alone |
| 2017-000831-16 | CNTO1275CRD1003 | A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants with Moderate to Severe Crohn’s Disease. |
| 2018-002979-17 | DOCTOS-Trial | Use of Doxapram as a new antiarrhythmic drug for a specific therapy of atrial fibrillation Doctos Trial (Doxapram conversion to sinus rhythm study) |
| 2017-001050-33 | Sensitize | An open-label Phase Ib/II, multi-center study of 4SC-202 in combination with pembrolizumab |
| 2016‐000432‐17 | GMMG - Concept | A Clinical Phase II, multicenter, Open‐label study evaluating iNduction, consolidation and maintenance treatment with Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I‐KRd) in Primary diagnosed high‐risk multiple myeloma paTients |
| 2016-000860-40 | CC-220-MM-001 | A phase 1b/2a multicenter, open-label, dose-escalation study to determine the maximum tolerated dose, assess the safety and tolerability, pharmacokinetics and preliminary efficacy of CC-220 monotherapy, in combination with dexamethasone, and in combination with dexamethasone and daratumumab or bortezomib in subjects with relapsed and refractory multiple myeloma |
| 2017-001997-41 | AMG701 | A Phase 1 open-lable study, evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of AMG701 in subjects with multiple myeloma. |
| 2017-001475-23 | GO39733 - Genentech | A phase Ia/Ib open-label, dose-escalation study of the safety and pharmacokinetics of RO7198457 as a single agent and in combination with atezolizumab in patients with locally advanced or metastatic tumors |
| 2019-001213-17 | Myr301 | A Multicenter, Open-label, Randomized Phase 3 Clinical Sudy to Assess Efficacy and Safety of bulevirtide in Patients with Chronic Hepatitis Delta |
| 2019-001759-38 | DOAC-Child | Pharmacokinetics of a microdosed cocktail containing rivaroxaban, apixaban and edoxaban in children with congenital heart defects |
| 2018-004076-35 | INCT Dara (Incyte) | A Randomized Open-Label Phase ½ Study of INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Participants with Relapsed or Refractory Multipe Myeloma |
| 2018-004767-31 | CC92480-MM-002 | Phase 1/2, multicenter, open-label, study to determine the recommended dose and regimen, and evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments in subjects with relapsed or refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM) |
| 2019-001932-80 | NI006 | A Phase I, First in Human, Double-Blind, Placebo-Controlled, Multicenter, Single and Multiple Ascending Dose Study of NI006 in Patients with Amyloid Transthyretin Cardiomyopathy followed by an Open-Label-Extension |
| 2019-000722-22 | ArHi | An open-label, phase 1, first-in-human, dose escalation and expansion study to evaluate the safety, tolerability, maximum tolerated or administered dose, pharmacokinetics, pharmacodynamics and tumor response profile of Aryl Hydrocarbon Receptor inhibitor (AhRi) BAY2416964 in participants with advanced solid tumors |
| 2020-002569-33 | Tacro-Johanniskraut | Assessment of the effect of drug formulation on the extent of the pharmacokinetic interaction between St. John’s Wort and tacrolimus (K700) |
| 2019-001743-48 | WVT078 | A Phase I, open-label, multicenter, study of WVT078 in subjects with relapsed and/or refractory multiple myeloma |
| 2020-001017-20 | Voriconazol-Clearance | Relative contribution of CYP3A and CYP2C19 to the oral clearance of voriconazole |
| 2019-003047-30 | DREAMM9 | A Phase 3, Randomized, Open-Label Study of Belantamab Mafodotin Administered in Combination with Bortezomib, Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone Alone in Participants with Newly Diagnosed Multiple Myeloma who are Ineligible for Autologous Stem Cell Transplantation |
| 2020-003984-24 | MDZ-Print | Evaluation of the perpetrator characteristics of metamizole (dipyrone) on the activity of CYP3A4 in healthy volunteers by using a new orodispersible film formulation of midazolam |
| 2020-001470-30 | HCQ Studie | Impact of pantoprazole on absorption and disposition of hydroxychloroquine, a drug used in Corona Virus Disease-19 (Covid-19) |
| 2020-004557-73 | REPO Studie | Clinical evaluation in healthy volunteers of potential syneRgistic vascular Effects of PrOpylthiouracil, riociguat, and perphenazine a possible STROKE medication |
| 2020-000926-24 | Match_HDIT | A Randomised, Double-Blind Phase II Trial of Topical HDIT101 versus Placebo in Patients with Chronic Recurrent HSV-1 Infection and Orolabial Lesion |
| freie Studie | COV-001_HDIT | Evaluation von SARS-CoV-2-spezifischen Serumparametern in Blutproben von SARS-CoV-2-seronegativen Probanden, akut an COVID-19 erkrankten hospitalisierten Patienten sowie ehemaligen Patienten mit abgeheilten asymptomatischen, milden bzw. schweren COVID-19-Verläufen (HTXCOV-01) |
| 2018-003352-20 | Imbrella | An open label, multicenter extension study in patients previously enrolled in a genentech and/or f. hoffmann-la roche ltd sponsored atezolizumab study (Imbrella b) |
| 2020-001038-36 | BNT162-01 | A multi-site, Phase I/II, 2-part, dose escalation trial investigating the safety and immunogenicity of four prophylactic SARS-CoV-2 RNA vaccines against COVID-19 using different dosing regimens in healthy and immunocompromised adults |
| 2021-002387-50 | BNT162-14 | A Phase II, open-label, rollover trial to evaluate the safety and immunogenicity of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 in BNT162-01 trial subjects, or two boosting doses of Comirnaty in BNT162-04 trial subjects |
| 2016-002122-36 | Tecli-MM-1001 | A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma |
| 2019-000330-19 | TRIMM | Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination with Bispecific T Cell Redirection Antibodies for the Treatment of Subjects with Multiple Myeloma |
| 2017-002400-26 | Talmmy | A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma |
| 2020-004533-21 | C1071003 | An open-label, multicenter, non-randomized phase 2 study of PF-06863135 monotherapy in participants with multiple myeloma who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody |
| 2020-003414-12 | HDP-101-01 | A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients with Plasma Cell Disorders Including Multiple Myeloma |
| 2018-004354-21 | DREAMM8 | A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) versus Pomalidomide plus Bortezomib and Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 8) |
