Table 1.
Relaxin clinical trials (source: ClinicalTrials.gov)
| Status and phase | Study title and dates | Sponsor and identifier | ||
|---|---|---|---|---|
| 1 | Completed, Phase II and III, n = 1161 | Efficacy and safety of relaxin for the treatment of acute heart failure/2007–2012 | Corthera/Novartis NCT00520806 | |
| Condition | Heart failure, congestive | |||
| Intervention | Drug: rhRLN | |||
| 2 | Terminated, Phase II, n = 11 | Recombinant human relaxin for the treatment of decompensated CHF/2006–2007 | Corthera/Novartis NCT00406575 | |
| Condition | Heart failure, congestive | |||
| Intervention | Drug: rhRLN | |||
| 3 | Completed, Phase II, n = 18 | A pilot study of recombinant human relaxin (rhRlx) in compensated CHF/2005– | Corthera/Novartis NCT00259116 | |
| Condition | Heart failure, congestive | |||
| Intervention | Drug: rhRLN | |||
| 4 | Suspended, Phase I, n = 18 (estimated) | Evaluation of the safety of relaxin in preeclampsia/2005– | Corthera/Novartis CT00333307 | |
| Condition | Pre‐eclampsia | |||
| Intervention | Drug: rhRLN | |||
| 5 | Terminated, Phase II, n = 3 | Safety and efficacy of RLX030 in pregnant women with pre‐eclampsia/2013–2014 | Novartis Pharmaceuticals NCT01566630 | |
| Condition | Pre‐eclampsia | |||
| Intervention | RLX030 | |||
| 6 | Completed, Phase III, n = 231 | Recombinant human relaxin in the treatment of diffuse scleroderma/1998–2001 | University of Medicine and Dentistry of New Jersey NCT00704665 | |
| Condition: | Systemic sclerosis | |||
| Intervention | Drug: rhRLN | |||
| 7 | Recruiting, Observational n = 30 (estimated) | Relaxin in multiple sclerosis (MS)/2013– | Providence Health & Services NCT01909492 | |
| Condition | Multiple sclerosis, relapsing‐remitting | |||
| Interventions | Procedure: blood draw; | |||
| Procedure: lumbar puncture | ||||
| 8 | Completed, Phase II, n = 1 | Phase II study of recombinant relaxin for progressive systemic sclerosis/1991–1997 | National Center for Research Resources (NCRR) NCT00004380 | |
| Condition | Systemic Sclerosis | |||
| Intervention | Drug: rhRLN | |||
| 9 | Completed, Phase II, n = 72 | Recombinant human relaxin (rhRlx) in pregnant women scheduled for induction of labour/2005–2006 | Corthera/Novartis NCT00259103 | |
| Condition | Labour, induced | |||
| Intervention | Drug: rhRLN | |||
| 10 | Recruiting, Phase II n = 60 (estimated) | Study of the vascular effects of serelaxin/2014– | Novartis Pharmaceuticals NCT01979614 | |
| Condition | Coronary artery disease | |||
| Intervention | Drug: rhRLN | |||
| 11 | Not yet recruiting Phase II, n = 20 (estimated) | Serelaxin to lower portal pressure/2016– | University of Edinburgh, Novartis Pharmaceuticals and NHS Lothian NCT02669875 | |
| Conditions | Liver cirrhosis; hypertension, portal | |||
| Intervention | Drug: rhRLN | |||
| 12 | Completed, Phase II, n = 47 | An exploratory haemodynamic study in patients with compensated cirrhosis and portal hypertension/2012–2014 | Novartis Pharmaceuticals NCT01640964 | |
| Condition | Compensated cirrhosis and portal hypertension | |||
| Intervention | Drug: terlipressin acetate; serelaxin | |||
| 13 | Completed, Phase II, n = 321 | Safety of repeat doses of IV serelaxin in subjects with chronic heart failure/2014–2015 | Novartis Pharmaceuticals NCT01982292 | |
| Condition | Chronic heart failure | |||
| Intervention | Drug: serelaxin | |||
| 14 | Recruiting, Phase II, n = 125 (estimated) | Study of the effect of serelaxin on high‐sensitivity cardiac tropin I release in patients with chronic heart Failure/2016‐ | Novartis Pharmaceuticals NCT02625922 | |
| Condition | Chronic heart failure | |||
| Intervention | Drug: serelaxin | |||
| 15 | Completed, Phase II, n = 46 | Study of safety, tolerability and pharmacokinetics of serelaxin in Japanese acute heart failure (AHF) patients/2014 | Novartis Pharmaceuticals NCT02002702 | |
| Condition | Acute heart failure | |||
| Intervention | Drug: serelaxin | |||
| 16 | Recruiting, Phase III, n = 2685 (estimated) | Effect of serelaxin versus standard of care in acute heart failure (AHF) patients/2014– | Novartis Pharmaceuticals NCT02064868 | |
| Condition | Acute heart failure; systolic blood pressure ≥125 mmHg,; mild‐to‐moderate renal impairment | |||
| Intervention | Drug: serelaxin; standard of care | |||
| 17 | Completed, Phase I, n = 36 | PK of Serelaxin in severe renal impairment and end stage renal disease/2013 | Novartis Pharmaceuticals NCT01875523 | |
| Condition | Renal failure, chronic; end‐stage renal disease | |||
| Intervention | Drug: serelaxin | |||
| 18 | Recruiting, Phase III, n = 1520 (estimated) | Efficacy, safety and tolerability of sexelaxin when added to standard therapy in AHF/2014– | Novartis Pharmaceuticals NCT02007720 | |
| Condition | Acute heart failure | |||
| Intervention | Drug: serelaxin | |||
| 19 | Recruiting, Phase II, n = 36 (estimated) | Pharmacokinetics and safety of serelaxin on top of standard of care therapy in pediatric patients with acute heart failure/2014– | Novartis Pharmaceuticals NCT02151383 | |
| Condition | Acute Heart Failure | |||
| Intervention | Drug: serelaxin | |||
| 20 | Recruiting, Phase III, n = 6800 (estimated) | Efficacy, safety and tolerability of serelaxin when added to standard therapy in AHF/2013‐ | Novartis Pharmaceuticals NCT01870778 | |
| Condition | Acute Heart failure | |||
| Intervention | Drug: serelaxin | |||
| 21 | Completed, Phase II, n = 71 | Haemodynamic responses to RLX030 infusion in subjects with acute heart failure/2012–2014 | Novartis Pharmaceuticals NCT01543854 | |
| Condition | Acute heart failure | |||
| Intervention | Drug: serelaxin | |||
rhRLN, Serelaxin or RLX30 is recombinant human relaxin 2. n, enrolment.