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CompletedNCT00513461Updated Aug 10, 2018Results posted

Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection

A Phase 2 interventional study of S-adenosyl-L-methionine disulfate p-toluene-sulfonate and placebo in Adult Primary Liver Cancer and Hepatitis C Infection, sponsored by Chao Family Comprehensive Cancer Center. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-10.

Sponsored by Chao Family Comprehensive Cancer Center · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This randomized phase II trial studies how well S-Adenosyl-L-Methionine Disulphate P-Toluene-Sulfonate (SAMe) works compared to a placebo in preventing liver cancer in patients with chronic hepatitis C infection. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of SAMe may keep cancer from forming in patients with advanced liver disease

Read the detailed description

PRIMARY OBJECTIVE:

I. To determine whether treatment with SAMe for 24 weeks reduces serum level of alpha-fetoprotein (AFP) in patients with advanced liver disease due to chronic hepatitis C.

SECONDARY OBJECTIVE:

I. To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma carboxyprothrombin (DCP) and alpha-fetoprotein-L3 (AFP-L3) in patients with advanced liver disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers).

II. To determine whether treatment with SAMe for 24 weeks alters biochemical markers of liver disease (e.g., serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], albumin, or bilirubin, etc.) and hepatitis C viral load in patients with advanced liver disease due to chronic hepatitis C (hepatitis C liver disease).

III. To determine whether treatment with SAMe for 24 weeks reduces serum levels of tumor necrosis factor-alpha (TNF-alpha), plasma levels of malondialdehyde (MDA), 4-hydroxynonenal (4-HNE) and urine levels of F2-isoprostane in patients with advanced liver disease due to chronic hepatitis C (oxidative stress).

IV. To determine whether treatment with SAMe for 24 weeks reduces plasma levels of methionine and homocysteine and increases plasma glutathione (GSH) and SAMe in patients with advanced liver disease due to chronic hepatitis C (SAMe metabolites).

V. To determine the safety, tolerability and quality of life of SAMe treatment (up to 2,400 mg/day) for 24 weeks in patients with advanced liver disease due to chronic hepatitis C.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive SAMe orally (PO) twice daily (BID) for 24 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO once daily (QD) for weeks 1-4, PO BID for weeks 5-8, and PO three times daily (TID) for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 6 weeks.

02

Conditions studied

  • Adult Primary Liver Cancer
  • Hepatitis C Infection
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 110 is close to the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

This is the only study on the registry with Chao Family Comprehensive Cancer Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chronic hepatitis C infection diagnosed by presence of hepatitis C ribonucleic acid (RNA) in serum by test of hepatitis C virus (HCV) RNA
  • No significant alcohol use (7 or fewer drinks per week) for the past 12 months
  • Serum AFP (at screening) between 15 and 100 ng/mL (15 ng/mL =\< AFP =\< 100 ng/mL) as measured by the Bayer Advai Centaur chemiluminescence system OR Serum AFP between 10 and 100 ng/mL (10 ng/mL =\< AFP =\<100 ng/mL) as measured by Diagnostic Products Corporation Immulite assay system OR AFP between 12 and 100 ng/mL (12 ng/mL =\< AFP =\< 100 ng/mL) as measured by Ortho ECiQ assay system
  • Evidence of advanced liver disease based on one or more of the following:
  • Platelet count less than 150,000/mm\^3
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio > 0.75
  • Liver biopsy demonstrating bridging fibrosis or cirrhosis
  • No treatment with interferon (recombinant interferon alfa), peginterferon (PEG-interferon alfa-2b), or ribavirin for at least 4 months, and not anticipated to start specific treatment for hepatitis C during the study (30 weeks)
  • Ultrasound (or adequate computed tomography [CT] or magnetic resonance imaging [MRI]) examination of the liver within 6 months prior to randomization revealing no masses in the liver suggestive of hepatocellular carcinoma
  • Willing to refrain from consuming over-the-counter SAMe and vitamin pills containing B-vitamins while participating in this study (30 weeks)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Leukocytes > 1,000/ mm\^3
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

Exclusion Criteria:

  • Liver disease other than from hepatitis C (e.g., hepatitis B, hemochromatosis, fat in more than 33% of hepatocytes, if liver biopsy has been performed., etc.); subjects with a past history of alcohol use can be enrolled into the study provided they have consumed less than 7 drinks/week for the past 12 months
  • Evidence of mass in liver by radiologic examination that is suggestive of hepatocellular carcinoma within 6 months prior to randomization
  • Model for End-Stage Liver Disease (MELD) score greater than 15 within 60 days prior to enrollment
  • Ascites which is clinically detectable
  • Use of SAMe during 4 months prior to randomization
  • Hospitalization within the past 5 years for mania or for bipolar disease
  • Concurrent use of monoamine oxidase inhibitors (MAO) or other drugs that increase the concentration of serotonin
  • Participants may not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAMe
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Children are excluded from this study but will be eligible for future pediatric trials, if applicable
  • Pregnant women are excluded from this study; serum pregnancy must be performed and be negative in all women of child bearing potential within 2 weeks prior to enrollment; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SAMe, breastfeeding should be discontinued if the mother is treated with SAMe
  • Subjects with any medical psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation in and compliance with the study criteria
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Arm I (SAMe)

    Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

    Drug: S-adenosyl-L-methionine disulfate p-toluene-sulfonate · Other: laboratory biomarker analysis · Other: immunoenzyme technique · Other: high performance liquid chromatography

  • Placebo comparator
    Arm II (placebo)

    Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.

    Other: placebo · Other: laboratory biomarker analysis · Other: immunoenzyme technique · Other: high performance liquid chromatography

Interventions

  • DrugS-adenosyl-L-methionine disulfate p-toluene-sulfonate

    Given PO

    Also known as: SAMe disulfate p-toluene-sulfonate

  • Otherplacebo

    Given PO

    Also known as: PLCB

  • Otherlaboratory biomarker analysis

    Correlative studies

  • Otherimmunoenzyme technique

    Correlative studies

    Also known as: immunoenzyme techniques

  • Otherhigh performance liquid chromatography

    Correlative studies

    Also known as: HPLC

06

What researchers measure

Primary outcomes

  1. Change in Serum AFP Levels

    Measured using an Food and Drug Administration (FDA)-approved assay. Mean change over time for the SAMe and placebo groups will be estimated. Differences in the change over time between the treated and control groups will be tested using a two-group repeated measures analysis of variance model.

    Time frame: Baseline to week 24

Secondary outcomes

  1. Treatment-related Changes in Serum DCP for Hepatocellular Carcinoma

    To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma carboxyprothrombin (DCP) in patients with advanced liver disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers).

    Time frame: Baseline to week 24

  2. Treatment-related Changes in Serum AFP-L3 (Expressed as the Percentage of Total AFTP) for Hepatocellular Carcinoma

    AFP-L3 assay will be performed by Wako Laboratories using their LiBASys platform.

    Time frame: Baseline to week 24

  3. SAMe

    Change in SAMe levels

    Time frame: Baseline to week 24

  4. Change in SAMe Metabolites - S-adenosylhomocysteine (SAH)

    S-adenosylhomocysteine (SAH)

    Time frame: Baseline to week 24

  5. Change in SAMe Metabolites - Methionine

    Methionine will be measured using HPLC with fluorescence detection.

    Time frame: Baseline to week 24

  6. Change in SAMe Metabolites - Total Homocysteine (tHcy)

    Total homocysteine (tHcy)

    Time frame: Baseline to week 24

  7. Change in SAMe Metabolites - Plasma GSH

    Plasma GSH will be measured using HPLC with fluorescence detection.

    Time frame: Baseline to week 24

  8. Change in SAMe Metabolites - Malondialdehyde (MDA)

    malondialdehyde

    Time frame: Baseline to week 24

  9. Change in SAMe Metabolites - 4-hydroxynonenal (4-HNE)

    Serum marker of oxidative stress. One mechanism by which SAMe is hypothesized to be beneficial is by reducing oxidative stress.

    Time frame: Baseline to week 24

  10. Change in Markers of Liver Disease - AST

    AST measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.

    Time frame: Baseline to week 24

  11. Change in Markers of Liver Disease - ALT

    ALT measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.

    Time frame: Baseline to week 24

  12. HCV RNA

    Change in HCV RNA levels. Serum level of HVC RNA was measured using COBAS TaqMan HCV test (Roche Molecular Systems).

    Time frame: Baseline to week 24

  13. Changes in Quality of Life - Physical Score

    Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Physical Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change in QOL = (Week 24 score - Baseline score).

    Time frame: Baseline to week 24

  14. Changes in Quality of Life - Mental Score

    Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Mental Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change = (Week 24 score - Baseline score).

    Time frame: Baseline to week 24

07

Results

Posted Aug 10, 2018

Participant flow

Participant flow — Overall Study
MilestoneArm I (SAMe)Arm II (Placebo)
Started5753
Completed4443
Not completed1310

Outcome measures

PrimaryChange in Serum AFP Levels

Measured using an Food and Drug Administration (FDA)-approved assay. Mean change over time for the SAMe and placebo groups will be estimated. Differences in the change over time between the treated and control groups will be tested using a two-group repeated measures analysis of variance model.

Time frame:
Baseline to week 24
Reported as:
Mean · ng/mL
Change in Serum AFP Levels
ng/mLArm I (SAMe)Arm II (Placebo)
Change in Serum AFP Levels-1.928 ± 20.3045.855 ± 29.207
Statistical analysis
  • Arm I (SAMe) vs Arm II (Placebo) · Wilcoxon (Mann-Whitney) · p = 0.160 · Mean difference (net): 7.78
SecondaryTreatment-related Changes in Serum DCP for Hepatocellular Carcinoma

To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma carboxyprothrombin (DCP) in patients with advanced liver disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers).

Time frame:
Baseline to week 24
Reported as:
Mean · ng/mL
Treatment-related Changes in Serum DCP for Hepatocellular Carcinoma
ng/mLArm I (SAMe)Arm II (Placebo)
Treatment-related Changes in Serum DCP for Hepatocellular Carcinoma0.259 ± 0.9760.647 ± 1.491
SecondaryTreatment-related Changes in Serum AFP-L3 (Expressed as the Percentage of Total AFTP) for Hepatocellular Carcinoma

AFP-L3 assay will be performed by Wako Laboratories using their LiBASys platform.

Time frame:
Baseline to week 24
Reported as:
Mean · percentage of AFP-L3/AFP
Treatment-related Changes in Serum AFP-L3 (Expressed as the Percentage of Total AFTP) for Hepatocellular Carcinoma
percentage of AFP-L3/AFPArm I (SAMe)Arm II (Placebo)
Treatment-related Changes in Serum AFP-L3 (Expressed as the Percentage of Total AFTP) for Hepatocellular Carcinoma0.144 ± 1.1460.335 ± 3.486
SecondarySAMe

Change in SAMe levels

Time frame:
Baseline to week 24
Reported as:
Mean · nmol/L
SAMe
nmol/LArm I (SAMe)Arm II (Placebo)
SAMe414.242 ± 744.373-9.085 ± 54.621
SecondaryChange in SAMe Metabolites - S-adenosylhomocysteine (SAH)

S-adenosylhomocysteine (SAH)

Time frame:
Baseline to week 24
Reported as:
Mean · nmol/L
Change in SAMe Metabolites - S-adenosylhomocysteine (SAH)
nmol/LArm I (SAMe)Arm II (Placebo)
Change in SAMe Metabolites - S-adenosylhomocysteine (SAH)16.326 ± 28.212-3.456 ± 13.104
SecondaryChange in SAMe Metabolites - Methionine

Methionine will be measured using HPLC with fluorescence detection.

Time frame:
Baseline to week 24
Reported as:
Mean · µmol/L
Change in SAMe Metabolites - Methionine
µmol/LArm I (SAMe)Arm II (Placebo)
Change in SAMe Metabolites - Methionine0.421 ± 18.794-2.894 ± 23.669
SecondaryChange in SAMe Metabolites - Total Homocysteine (tHcy)

Total homocysteine (tHcy)

Time frame:
Baseline to week 24
Reported as:
Mean · µmol/L
Change in SAMe Metabolites - Total Homocysteine (tHcy)
µmol/LArm I (SAMe)Arm II (Placebo)
Change in SAMe Metabolites - Total Homocysteine (tHcy)0.266 ± 2.394-0.677 ± 2.478
SecondaryChange in SAMe Metabolites - Plasma GSH

Plasma GSH will be measured using HPLC with fluorescence detection.

Time frame:
Baseline to week 24
Reported as:
Mean · µmol/L
Change in SAMe Metabolites - Plasma GSH
µmol/LArm I (SAMe)Arm II (Placebo)
Change in SAMe Metabolites - Plasma GSH0.455 ± 1.4250.285 ± 1.23
SecondaryChange in SAMe Metabolites - Malondialdehyde (MDA)

malondialdehyde

Time frame:
Baseline to week 24
Reported as:
Mean · µmol/L
Change in SAMe Metabolites - Malondialdehyde (MDA)
µmol/LArm I (SAMe)Arm II (Placebo)
Change in SAMe Metabolites - Malondialdehyde (MDA)-0.007 ± 0.848-0.002 ± 1.162
SecondaryChange in SAMe Metabolites - 4-hydroxynonenal (4-HNE)

Serum marker of oxidative stress. One mechanism by which SAMe is hypothesized to be beneficial is by reducing oxidative stress.

Time frame:
Baseline to week 24
Reported as:
Mean · µg/mL
Change in SAMe Metabolites - 4-hydroxynonenal (4-HNE)
µg/mLArm I (SAMe)Arm II (Placebo)
Change in SAMe Metabolites - 4-hydroxynonenal (4-HNE)-0.185 ± 0.716-0.032 ± 0.448
SecondaryChange in Markers of Liver Disease - AST

AST measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.

Time frame:
Baseline to week 24
Reported as:
Mean · IU/L
Change in Markers of Liver Disease - AST
IU/LArm I (SAMe)Arm II (Placebo)
Change in Markers of Liver Disease - AST-0.755 ± 37.5311.723 ± 40.709
SecondaryChange in Markers of Liver Disease - ALT

ALT measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.

Time frame:
Baseline to week 24
Reported as:
Mean · IU/L
Change in Markers of Liver Disease - ALT
IU/LArm I (SAMe)Arm II (Placebo)
Change in Markers of Liver Disease - ALT-9.548 ± 34.7860.019 ± 41.165
SecondaryHCV RNA

Change in HCV RNA levels. Serum level of HVC RNA was measured using COBAS TaqMan HCV test (Roche Molecular Systems).

Time frame:
Baseline to week 24
Reported as:
Mean · IU/mL
HCV RNA
IU/mLArm I (SAMe)Arm II (Placebo)
HCV RNA-259327.69 ± 3084015.42-19968.89 ± 2425010.48
SecondaryChanges in Quality of Life - Physical Score

Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Physical Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change in QOL = (Week 24 score - Baseline score).

Time frame:
Baseline to week 24
Reported as:
Mean · units on a scale
Changes in Quality of Life - Physical Score
units on a scaleArm I (SAMe)Arm II (Placebo)
Changes in Quality of Life - Physical Score-0.4 ± 11.730.03 ± 13.6
Statistical analysis
  • Arm I (SAMe) vs Arm II (Placebo) · Two-Group t-test · p = 0.878 · Mean difference (net): 0.43
SecondaryChanges in Quality of Life - Mental Score

Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Mental Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change = (Week 24 score - Baseline score).

Time frame:
Baseline to week 24
Reported as:
Mean · scores on a scale
Changes in Quality of Life - Mental Score
scores on a scaleArm I (SAMe)Arm II (Placebo)
Changes in Quality of Life - Mental Score0.83 ± 15.06-2.83 ± 11.76
Statistical analysis
  • Arm I (SAMe) vs Arm II (Placebo) · Two-Group t-test · p = 0.212 · Mean difference (net): -3.66

Adverse events

Collected over Through study completion, an average of 30 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I (SAMe)—5/57 (8.8%)51/57 (89.5%)
Arm II (Placebo)—3/53 (5.7%)46/53 (86.8%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventArm I (SAMe)Arm II (Placebo)
ABDOMINAL CELLULITISInfections and infestations0/571/53
ANGIOPLASTY OF LEFT HYPOGASTRIC ARTERY, EXTERNAL ILIAC STENT PLACEMENT FOR LEFT LEGVascular disorders0/571/53
HEPATOCELLULAR CARCINOMAHepatobiliary disorders0/571/53
LEFT THIGH ABSCESSInfections and infestations0/571/53
ABDOMINAL DISCOMFORTGastrointestinal disorders1/570/53
ABDOMINAL PAIN.STATUS POST SPLENIC ARTERY EMBOLIZATIONGastrointestinal disorders1/570/53
NEPHROTIC SYNDROMERenal and urinary disorders1/570/53
NON-ST ELEVATION MIOCARDIAL INFARCTIONCardiac disorders1/570/53
PNEUMONIAInfections and infestations1/570/53
SMALL BOWEL INFLAMATIONGastrointestinal disorders1/570/53
Most frequent other events
Showing 10 of 165
Most frequent other events
EventArm I (SAMe)Arm II (Placebo)
FLATULENCEGastrointestinal disorders19/5722/53
STOMACH PAINGastrointestinal disorders21/579/53
DIARRHEAGastrointestinal disorders20/5713/53
NAUSEAGastrointestinal disorders18/577/53
FATIGUEGeneral disorders15/579/53
HEADACHENervous system disorders13/5711/53
DRY MOUTHGastrointestinal disorders10/5712/53
CONSTIPATIONGastrointestinal disorders12/575/53
INCREASED URINATIONRenal and urinary disorders12/579/53
INSOMNIAPsychiatric disorders9/578/53

Baseline characteristics

Age, Continuous
Age, Continuous(years)Arm I (SAMe)Arm II (Placebo)Total
Mean58.5 ± 4.957.2 ± 5.857.88 ± 5.33
Sex: Female, Male
Sex: Female, Male(Participants)Arm I (SAMe)Arm II (Placebo)Total
Female9615
Male484795
08

Study locations

5 sites
  • University of Arizona Health Sciences Center
    Tucson, Arizona 85724, United States
  • Veterans Administration Long Beach Medical Center
    Long Beach, California 90822, United States
  • Veterans Administration Los Angeles Healthcare System
    Los Angeles, California 90073, United States
  • Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • University of California At San Diego
    San Diego, California 92103, United States
09

References and documents

Publications

  • Morgan TR, Osann K, Bottiglieri T, Pimstone N, Hoefs JC, Hu KQ, Hassanein T, Boyer TD, Kong L, Chen WP, Richmond E, Gonzalez R, Rodriguez LM, Meyskens FL. A Phase II Randomized, Controlled Trial of S-Adenosylmethionine in Reducing Serum alpha-Fetoprotein in Patients with Hepatitis C Cirrhosis and Elevated AFP. Cancer Prev Res (Phila). 2015 Sep;8(9):864-72. doi: 10.1158/1940-6207.CAPR-15-0029. Epub 2015 Jun 30. PubMed 26130251 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00513461
Lead sponsor
Chao Family Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Chao Family Comprehensive Cancer Center (Cancer Center, University of California, Irvine) — Sponsor-investigator
First posted
Aug 8, 2007
Start date
Oct 2007
Primary completion
Aug 2012
Completion
Dec 2013
Results posted
Aug 10, 2018
Last update
Aug 10, 2018

Study contacts

John Hoefs
principal investigator · Chao Family Comprehensive Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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