Jaundice; MalignantPhase 3NCT03416062
Remaxol® in Malignant Mechanical Jaundice
A Phase 3 study testing Remaxol® and Ringer's Solution in people with Jaundice; Malignant, run by POLYSAN Scientific & Technological Pharmaceutical Company at 18 sites in Russia.
Trial summary
The trial intends to study the safety and efficacy of Remaxol® (succinate + methionine + inosine + nicotinamide; POLYSAN Ltd., Russia),solution for infusion for the reduction of hyperbilirubinemia in patients with obstructive jaundice caused by tumor (malignancy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jaundice; Malignant
- What is being tested?
- Remaxol® and Ringer's Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 18 sitesRussia
- Study dates
- 3 Apr 2017to 4 Mar 2020
- Phase
- Phase 3
- 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
- Presence of signed informed consent for participation in the study.
- Men and women over 18 years of age (incl.).
- Demonstrated by one or several instrumental methods (ultrasound, cholangiography, CT or MRI) enlargement of intrahepatic bile ducts with visualized obturation of the main bile ducts caused by tumor.
- Duration of mechanical jaundice less than 30 days, including the first day of the screening period.
- The status by the classifications Eastern Cooperative Oncology Group (ECOG) scale is 0-2.
- Life expectancy of more than 3 months.
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- Laboratory data corresponding to the following cutoff limits :
- hemoglobin ≥90 g / l; neutrophils ≥ 1.5x109 / l; Platelets ≥ 75 x 109 / L; AsAT and / or AlAT above 3 х normal but less than 25 х normal Serum creatinine not exceeding 2 × normal, Serum potassium within normal limits
- Negative urine test for pregnancy in women of reproductive age.
- For reproductive age: consent to use adequate methods of contraception or for complete abstinence from sexual activity for the period of the study.
Who cannot join
- Radical surgery planned within 10 days from the date of randomization.
- Liver metastases with the biliary block at the level of segmental ducts.
- Suspicion of metastases in the central nervous system or metastatic arachnoiditis during physical examination; clinically significant ascites.
- Acute destructive pancreatitis, diffuse peritonitis, ongoing bleeding of any etiology, sepsis (procalcitonin test of 10 ng / ml and above).
- Liver cirrhosis
- Presence of clinically significant cardiovascular diseases: chronic cardiac insufficiency III-IV functional class by NYHA, uncontrolled arterial hypertension, acute stroke or acute myocardial infarction in the previous 3 months, unstable angina, uncontrolled arrhythmia and severe heart rhythm disturbances.
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- Pregnancy or lactation.
- Hypersensitivity to any component of the study drug / placebo and / or intolerance to any component of the study drug / placebo.
- Regular intake of medications prohibited or not permitted by the study protocol within 4 weeks prior to enrollment or medical indication tio start any medication prohibited or not permitted by the study protocol
- Concomitant chronic systemic immune or hormonal therapy.
- Gout.
- Alcohol and/or drug dependence.
- Active tuberculosis, HIV infection, syphilis, acute viral hepatitis.
- Any other conditions / diseases that may interfere with the patient's compliance with the requirements of the Protocol.
- Mental, physical and other reasons that do not allow the patient to comply with the requirements of the study protocol.
- Any other significant (by judgement of the investigator) condition that prevents the patient from entering the study.
- Participation in any clinical trial in the previous 3 months.
- Staff of the research center and their family members.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Russia18 sites
GBUZ 'Bryansk City Hospital #1'
Bryansk
Regional Clinical Hospital of Emergency Care n.a.M.A.Podgorbunsky
Kemerovo
KBUZ 'Regional Clinical Hospital'
Krasnoyarsk
OBUZ 'Kursy Regional Clinical Oncology Dispensary' of Kursky Regional Healthcare Department
Kursk
Moscow City Clinical Hospital #1 n.a.N.I.Pirogov
Moscow
Moscow City Clinical Hospital #29 n.a.N.A.Bauman
Moscow
Omsk Regional Clinical Oncology Center
Omsk
GBUZ "Penza Regional Clinical Hospital na N.N.Burdenko"
Penza
City Clinical Hospital of Emergency Care
Ryazan
GBUZ 'Leningrad Regional Oncology Center'
Saint Petersburg
GBUZ Leningrad Regional Clinical Hospital
Saint Petersburg
Hospital for War Veterans
Saint Petersburg
North-West State Medical University named after I.I. Mechnikov
Saint Petersburg
Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine
Saint Petersburg
SPb GBUZ "City Hospital №26"
Saint Petersburg
SPb GBUZ 'City Mariinskaya Hospital'
Saint Petersburg
OGAUZ "Tomsk Regional Clinical Hospital"
Tomsk
Siberian State Medical University
Tomsk
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized Trial of the Efficacy and Safety of Remaxol®, a Solution for Infusions Produced by STPF POLYSAN (Russia), in Patients With Malignant Mechanical Jaundice
The trial intends to study the safety and efficacy of Remaxol® (succinate + methionine + inosine + nicotinamide; POLYSAN Ltd., Russia),solution for infusion for the reduction of hyperbilirubinemia in patients with obstructive jaundice caused by tumor (malignancy).
Read the detailed description
The study will recruit in-hospital surgical patients with obstructive jaundice caused by malignancies of pancreatic and hepatobiliary zone.
The study consists of the following periods:
- Screening - preliminary examination of patients (duration up to 3 days).
- Period of therapy (including surgery and postoperative period) - treatment with the investigational product Remaxol®, solution for infusions, (NTFF POLYSAN Ltd., Russia) or placebo, as part of standard infusion therapy during the postoperative period of patients with mechanical jaundice of malignant origin (duration 10 days).
- The period of follow-up (duration - 3 weeks after the end of treatment).
After the screening, patients who meet the inclusion criteria and do not have exclusion criteria will be randomly assigned to three groups (1:1:1):
- Group I: treatment with Remaxol® 400 ml IV, and placebo (Ringer solution) 400 ml IV, once a day for 10 days, along with standard infusion therapy.
- Group II: treatment Remaxol® 800 ml IV, once a day for 10 days, along with standard infusion therapy.
- Group III: patients will receive placebo ((Ringer solution) 800 ml IV, once a day for 10 days, along with standard infusion therapy.
Assessment will include physical examination data, vital signs, blood tests (CBC, biochemistry - protein, albumin, AST, ALT, APG, GGTP, LDH, total bilirubin, direct bilirubin, amylase, glucose, electrolytes, creatinine, urea, uric acid, C -reactive protein, lipid profile; coagulogram; urine samples), ECOG assessment, repeated abdominal ultrasound, neurophysiological test for the evaluation of encephalopathy, record of bile volume by drainage (if applicable).
All patients will be followed up for 31 days.
- Conditions
- Jaundice; Malignant
- Being tested
- Remaxol®, Ringer's Solution
- Keywords
- Jaundice, obstructive, Methionine, Succinic acid
- Medical subject headings
- Jaundice, Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remaxol®Drug
Also called Remaxol (succinate + methionine + inosine + nicotinamide)
Solution for intravenous infusions, containing succinate, methionine, inosine, and nicotinamide in 400 ml glass bottle
Ringer's SolutionDrug
Also called Placebo
Solution for intravenous infusion, 400 or 800 ml
| Study group | Role | What they receive |
|---|---|---|
| Remaxol® 400 ml + Placebo 400 ml | Experimental | Treatment with Remaxol® 400 ml IV + Ringer solution 400 ml IV for 10 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide) Receives: Drug: Remaxol®; Drug: Ringer's Solution |
| Remaxol® 800 ml | Experimental | Treatment with Remaxol® 800 ml IV for 10 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide) Receives: Drug: Remaxol® |
| Control | Placebo comparator | Treatment with Ringer's solution 800 ml IV for 7 days. Drug: Ringer's solution Receives: Drug: Ringer's Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to regression of jaundice
The time (days) from the day of the drainage operation to the reduction of the total bilirubin level down to 90 μmol / l, in experimental (Remaxol®) vs. control (Placebo) groups
Measured: 21 days
Secondary outcomes (12)
Regression of cytolysis (normal alanine aminotransferase and aspartate aminotransferase serum levels)
Proportion of patients in study groups who reached normal serum levels of alanine aminotransferase and aspartate aminotransferase on day 11 from the start of treatment
Measured: 11 days
Regression of cholestasis
Proportion of patients in study groups who reached normal serum levels of alkaline phosphatase, GGTP, total bilirubin, and direct bilirubin on day 11 from the start of treatment
Measured: 11 days
Regression of encephalopathy
Proportion of patients in study groups who had normal brain functioning on day 11, as reflected by the neurophysiological test for the evaluation of the degree of encephalopathy
Measured: 11 days
Serum bilirubin
Dynamics of total and direct bilirubin serum levels against baseline values and between visits in the study groups
Measured: 21 days
Serum alkaline phosphatase
Dynamics of serum alkaline phosphatase level against baseline values and between visits in the study groups
Measured: 21 days
Serum GGTP
Dynamics of serum gamma-glutamyltranspeptidase level against baseline values and between visits in the study groups
Measured: 21 days
Serum alanine aminotransferase
Dynamics of serum alanine aminotransferase level against baseline values and between visits in the study groups
Measured: 21 days
Serum aspartate aminotransferase
Dynamics of serum aspartate aminotransferase level against baseline values and between visits in the study groups
Measured: 21 days
Liver function
State of liver protein synthesis function (as reflected by serum levels of total protein, albumin, INR, PT, PTI, APTT, fibrinogen) against baseline values and/or between visits
Measured: 21 days
Kidney function
State of kidney function (creatinine serum level) against baseline values and/or between visits
Measured: 21 days
Proportion of patients with complications of jaundice
The number of patients in the study groups who developed complications in the postoperative period which were, according to the researcher's assessment, causally related to the obstructive jaundice (for example, purulent cholangitis, sepsis, kidney failure)
Measured: 21 days
Eastern Cooperative Oncology Group (ECOG) Performance Status
Status of patients in the study groups by ECOG (Eastern Cooperative Oncology Group) grades at the end of the study. ECOG Performance Status consists of the following grades:
0 - fully active, able to carry on all pre-disease performance without restriction;
- - restricted but ambulatory and able to carry out work of a light or sedentary nature;
- - ambulatory and capable of all selfcare but unable to carry out any work activities;
- - capable of only limited selfcare; partially confined to bed or chair;
- - completely disabled; cannot carry on any selfcare;
- - Dead
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start3 Apr 2017
- Primary completion3 Feb 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaundice; MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikhail S. Bogomolov, MD, PhD, Study director, St. Petersburg State Medical University n.a. I.P.Pavlov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416062
- Sponsor's protocol ID
- REM-CJ-III-16
- Status last verified
- Jul 2020
- First submitted
- 23 Jan 2018
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled, Randomized Trial of the Efficacy and Safety of Remaxol®, a Solution for Infusions Produced by STPF POLYSAN (Russia), in Patients With Malignant Mechanical Jaundice
- ClinicalTrials.gov ID
- NCT03416062
- Acronym / sponsor ID
- REM-CJ-III-16
- Conditions
- Jaundice; Malignant
- Keywords
- Jaundice, obstructive, Methionine, Succinic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial intends to study the safety and efficacy of Remaxol® (succinate + methionine + inosine + nicotinamide; POLYSAN Ltd., Russia),solution for infusion for the reduction of hyperbilirubinemia in patients with obstructive jaundice caused by tumor (malignancy).
Detailed description
The study will recruit in-hospital surgical patients with obstructive jaundice caused by malignancies of pancreatic and hepatobiliary zone.
The study consists of the following periods:
- Screening - preliminary examination of patients (duration up to 3 days).
- Period of therapy (including surgery and postoperative period) - treatment with the investigational product Remaxol®, solution for infusions, (NTFF POLYSAN Ltd., Russia) or placebo, as part of standard infusion therapy during the postoperative period of patients with mechanical jaundice of malignant origin (duration 10 days).
- The period of follow-up (duration - 3 weeks after the end of treatment).
After the screening, patients who meet the inclusion criteria and do not have exclusion criteria will be randomly assigned to three groups (1:1:1):
- Group I: treatment with Remaxol® 400 ml IV, and placebo (Ringer solution) 400 ml IV, once a day for 10 days, along with standard infusion therapy.
- Group II: treatment Remaxol® 800 ml IV, once a day for 10 days, along with standard infusion therapy.
- Group III: patients will receive placebo ((Ringer solution) 800 ml IV, once a day for 10 days, along with standard infusion therapy.
Assessment will include physical examination data, vital signs, blood tests (CBC, biochemistry - protein, albumin, AST, ALT, APG, GGTP, LDH, total bilirubin, direct bilirubin, amylase, glucose, electrolytes, creatinine, urea, uric acid, C -reactive protein, lipid profile; coagulogram; urine samples), ECOG assessment, repeated abdominal ultrasound, neurophysiological test for the evaluation of encephalopathy, record of bile volume by drainage (if applicable).
All patients will be followed up for 31 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remaxol® 400 ml + Placebo 400 ml | Experimental | Drug: Remaxol®, Drug: Ringer's SolutionTreatment with Remaxol® 400 ml IV + Ringer solution 400 ml IV for 10 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide) |
| Remaxol® 800 ml | Experimental | Drug: Remaxol®Treatment with Remaxol® 800 ml IV for 10 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide) |
| Control | Placebo comparator | Drug: Ringer's SolutionTreatment with Ringer's solution 800 ml IV for 7 days. Drug: Ringer's solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Presence of signed informed consent for participation in the study.
- Men and women over 18 years of age (incl.).
- Demonstrated by one or several instrumental methods (ultrasound, cholangiography, CT or MRI) enlargement of intrahepatic bile ducts with visualized obturation of the main bile ducts caused by tumor.
- Duration of mechanical jaundice less than 30 days, including the first day of the screening period.
- The status by the classifications Eastern Cooperative Oncology Group (ECOG) scale is 0-2.
Key exclusion criteria (18 listed)
- Radical surgery planned within 10 days from the date of randomization.
- Liver metastases with the biliary block at the level of segmental ducts.
- Suspicion of metastases in the central nervous system or metastatic arachnoiditis during physical examination; clinically significant ascites.
- Acute destructive pancreatitis, diffuse peritonitis, ongoing bleeding of any etiology, sepsis (procalcitonin test of 10 ng / ml and above).
- Liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remaxol®Also: Remaxol (succinate + methionine + inosine + nicotinamide)Solution for intravenous infusions, containing succinate, methionine, inosine, and nicotinamide in 400 ml glass bottle | Drug | Remaxol® 400 ml + Placebo 400 ml, Remaxol® 800 ml |
| Ringer's SolutionAlso: PlaceboSolution for intravenous infusion, 400 or 800 ml | Drug | Control, Remaxol® 400 ml + Placebo 400 ml |
Primary outcome
Time to regression of jaundice
Time frame: 21 days
The time (days) from the day of the drainage operation to the reduction of the total bilirubin level down to 90 μmol / l, in experimental (Remaxol®) vs. control (Placebo) groups
12 secondary outcomes
Regression of cytolysis (normal alanine aminotransferase and aspartate aminotransferase serum levels)
Time frame: 11 days
Regression of cholestasis
Time frame: 11 days
Regression of encephalopathy
Time frame: 11 days
Serum bilirubin
Time frame: 21 days
Serum alkaline phosphatase
Time frame: 21 days
Serum GGTP
Time frame: 21 days
Serum alanine aminotransferase
Time frame: 21 days
Serum aspartate aminotransferase
Time frame: 21 days
Liver function
Time frame: 21 days
Kidney function
Time frame: 21 days
Proportion of patients with complications of jaundice
Time frame: 21 days
Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: 31 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Jaundice; Malignant
Not yet recruitingObservational study
Real-world Evaluation of Different Endoscopic Biliary Drainage Techniques in Patients With Jaundice of Biliopancreatic Malignant Origin
Biliary Drainage, Endoscopic Ultrasound-Guided Drainage
Not yet recruiting
Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Biliary Tract Neoplasms, Biliary Drainage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail S. Bogomolov, MD, PhD study director
St. Petersburg State Medical University n.a. I.P.Pavlov
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remaxol® and Ringer's Solution in people with Jaundice; Malignant, run by POLYSAN Scientific & Technological Pharmaceutical Company at 18 sites in Russia.
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 10 inclusion and 18 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 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time to regression of jaundice (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2020.