Dept. of Clinical Pharmacology and Pharmacoepidemiology
Dept. of Clinical Pharmacology and Pharmacoepidemiology
Dept. of Clinical… Clinical Trials Current trials

Current trials

In the Early Clinical Pharmacological Trial Unit, a broad spectrum of patients, ranging from healthy subjects up to severely ill patients is cared for. We conduct both self-initiated and industry-sponsored trials, primarily in the early phases.

If you come from academic research or industry and would like conduct your trial in our study center you can find out more on our page for sponsors.

Cooperative studies at Heidelberg University Hospital

Furthermore, trials are also conducted in cooperation with other departments and partners at Heidelberg University Hospital.

These include:

Trials with pediatric patients or primarily pneumological indications (including studies according to the Medical Devices Act) are conducted by our network partners, the Pediatric Clinical-Pharmacological Trial Center (paedKliPS) and the Pneumological Clinical-Pharmacological Trial Center (ThoraxKliPS).

Ongoing trials

Below you will find an overview of all currently running trials, which you can also download here as a pdf.

EudraCT - NUMBER SHORT TITLE DESIGN
2017-000785-29 DOAK - Geriatrics 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-label 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 Study 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-John's wort 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 Voriconazole 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 Study Impact of pantoprazole on absorption and disposition of hydroxychloroquine, a drug used in Corona Virus Disease-19 (Covid-19)
2020-004557-73 REPO Study 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
free trial COV-001_HDIT Evaluation of SARS-CoV-2-specific serum parameters in blood samples from SARS-CoV-2 seronegative subjects, hospitalized patients acutely ill with COVID-19, and former patients with resolved asymptomatic, mild, or severe COVID-19 courses (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)

 

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