AzTrials
AzTrials

Liver CirrhosisPhase 2STOPPNCT02669875

Serelaxin To Lower Portal Pressure

A Phase 2 study testing Serelaxin in people with Liver Cirrhosis and Hypertension, Portal, run by University of Edinburgh at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Portal hypertension (an increase in blood pressure in the portal vein that carries the blood from the intestine and spleen to the liver) underlies most of the serious complications of liver cirrhosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cirrhosis, Hypertension, Portal
What is being tested?
Serelaxin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteUnited Kingdom
Study dates
18 Oct 2017to 31 Aug 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female adult subjects over 18 years of age
  • Able to provide written informed consent and able to understand and willing to comply with the requirements of the study
  • Clinical imaging-diagnosed or biopsy-proven liver cirrhosis of any aetiology
  • Evidence of portal hypertension either on imaging or previous endoscopy
  • Patients with large/grade 3 varices as identified by endoscopy within 6 months of screening must be in an endoscopic band ligation programme at the time of study entry
  • Suspected hepatic venous pressure gradient (HVPG) ≥10 mmHg at baseline

Who cannot join

  • Pregnancy or breast feeding
  • Women of child-bearing potential not using highly effective methods of contraception
  • Severe liver failure defined by one of the following: Prothrombin activity <40%, Bilirubin >5 mg/dL (85umol/L), hepatic encephalopathy > grade I
  • A history of variceal bleed within 1 month prior to visit 1
  • Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk
  • Hepatocellular carcinoma or history of malignancy of any organ system (other than localized basal cell carcinoma of the skin) treated or untreated
Show all 22Show fewer
  • Portal vein thrombosis
  • Previous surgical shunt or TIPSS
  • Current use of beta-blockers or nitrates, any other drug therapy known to have an influence on portal pressure (diuretics permitted provided patients have been on a stable dose for at least 30 days)
  • History of drug or alcohol abuse within 1 month of enrolment
  • Sitting Systolic Blood Pressure <110 mmHg at screening visit or within 10 minutes prior to starting study drug infusion
  • Use of other investigational drugs within 5 half-lives of enrolment, or within 30 days/until the expected pharmacodynamic effect has returned to baseline, whichever is longer
  • Significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate < 45 beats per minute or atrial fibrillation/flutter with sustained ventricular response of > 90 beats per minute at rest, or Long QT syndrome or corrected QT interval (QTc) > 450 msec (QT correction will be performed using the Fridericia correction method: QTcF = QT/RR0.33) for males and > 460 msec for females at screening visit
  • Documented hypersensitivity to intravenous contrast agents and/or iodine
  • Severe renal impairment (eGFR<30mL/min /1.73m2)
  • Significant left ventricular outflow tract obstructions (e.g., severe valvular aortic stenosis, obstructive cardiomyopathy), severe mitral stenosis, restrictive amyloid myocardiopathy, acute myocarditis
  • Severe aortic insufficiency or severe mitral regurgitation for which surgical or percutaneous intervention is indicated
  • Major neurologic event including cerebrovascular events, within 30 days prior to screening
  • Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrolment
  • History of hypersensitivity to study drug serelaxin or study drug ingredients
  • Inability to follow instructions or comply with follow-up procedures.
  • Permanent pacemaker, cardiac resynchronisation device or implantable cardioverter-defibrillator in situ

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Liver Unit, Royal Infirmary of Edinburgh

    Edinburgh, EH164TJ

Other trials in United Kingdom

About this study

Official title: Serelaxin To Lower Portal Pressure in Patients With Cirrhosis and Portal Hypertension

Portal hypertension (an increase in blood pressure in the portal vein that carries the blood from the intestine and spleen to the liver) underlies most of the serious complications of liver cirrhosis. This randomised placebo controlled study in people with liver cirrhosis evaluates the acute effects serelaxin (RLX030) infusion on portal hypertension and liver blood flow.

Read the detailed description

This study will investigate the effects of the investigational drug serelaxin (a recombinant form of the peptide human relaxin-2) on portal hypertension in patients with liver cirrhosis. The investigators will measure portal pressure by hepatic venous pressure gradient (HVPG) and hepatic blood flow by indocyanine green (ICG) clearance to evaluate the potential benefits of the drug. In a recently completed small exploratory open-label phase 2 study (EudraCT no. 201200023626, NCT01640964), Part B demonstrated that serelaxin can lower portal pressure.

Being tested
Serelaxin, Placebo
Medical subject headings
Liver Cirrhosis, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SerelaxinDrug

    Also called RLX030, Recombinant human relaxin-2

    Serelaxin solution diluted in 5% glucose volume/volume (v/v) solution

  • PlaceboDrug

    Placebo solution (20mM sodium acetate pH5) diluted in 5% v/v glucose solution

Study groups in NCT02669875
Study groupRoleWhat they receive
SerelaxinActive comparatorIV infusion of serelaxin (RLX030) for 2 hours
Receives: Drug: Serelaxin
PlaceboPlacebo comparatorIV infusion of placebo (20mM sodium acetate pH5) matched to serelaxin for 2 hours
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in fasting hepatic venous pressure gradient (HVPG)

    Measured: Baseline, after 2 hours

Secondary outcomes (8)

  1. Change from baseline in fasting hepatic venous pressure gradient (HVPG)

    Measured: Baseline, after 1 hour

  2. Change from baseline in fasting hepatic blood flow

    Measured from the concentration of indocyanine green (ICG) in the hepatic venous blood vs peripheral venous blood using the Fick Principle

    Measured: Baseline, after 2 hours

  3. Change from baseline in inferior vena cava pressure

    Measured: Baseline, after 2 hours

  4. Change from baseline in cardiac index

    Measured: Baseline, after 2 hours

  5. Change from baseline in systemic vascular resistance index

    Measured: Baseline, after 2 hours

  6. Number of participants with adverse events

    Adverse events (AE) reporting will be summarized based on number of patients reported with abnormal laboratory values, clinically significant AE, serious adverse events or death

    Measured: 4 weeks

  7. Change from baseline in blood biomarker measurements

    Measured: Baseline, after 2 hours

  8. Change from baseline in aortic pulse wave velocity

    Measured: Baseline, after 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2016 (estimated)
  2. Study start18 Oct 2017
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02669875
Sponsor's protocol ID
STOPP
Acronym
STOPP
Status last verified
Oct 2018
First submitted
28 Jan 2016
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fallowfield JA, Hayden AL, Snowdon VK, Aucott RL, Stutchfield BM, Mole DJ, Pellicoro A, Gordon-Walker TT, Henke A, Schrader J, Trivedi PJ, Princivalle M, Forbes SJ, Collins JE, Iredale JP. Relaxin modulates human and rat hepatic myofibroblast function and ameliorates portal hypertension in vivo. Hepatology. 2014 Apr;59(4):1492-504. doi: 10.1002/hep.26627. Epub 2014 Mar 3.

    PubMed 23873655

  • Kobalava Z, Villevalde S, Kotovskaya Y, Hinrichsen H, Petersen-Sylla M, Zaehringer A, Pang Y, Rajman I, Canadi J, Dahlke M, Lloyd P, Halabi A. Pharmacokinetics of serelaxin in patients with hepatic impairment: a single-dose, open-label, parallel group study. Br J Clin Pharmacol. 2015 Jun;79(6):937-45. doi: 10.1111/bcp.12572.

    PubMed 25511105

  • Gifford FJ, Dunne PDJ, Weir G, Ireland H, Graham C, Tuck S, Hayes PC, Fallowfield JA. A phase 2 randomised controlled trial of serelaxin to lower portal pressure in cirrhosis (STOPP). Trials. 2020 Mar 12;21(1):260. doi: 10.1186/s13063-020-4203-9.

    PubMed 32164767

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Serelaxin in people with Liver Cirrhosis and Hypertension, Portal, run by University of Edinburgh at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in fasting hepatic venous pressure gradient (HVPG) (time frame: Baseline, after 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02669875, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.

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