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Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection

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ClinicalTrials.gov Identifier: NCT00513461
Recruitment Status : Completed
First Posted : August 8, 2007
Results First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions: Adult Primary Liver Cancer
Hepatitis C Infection
Interventions: Drug: S-adenosyl-L-methionine disulfate p-toluene-sulfonate
Other: placebo
Other: laboratory biomarker analysis
Other: immunoenzyme technique
Other: high performance liquid chromatography

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

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.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies


Participant Flow:   Overall Study
    Arm I (SAMe)   Arm II (Placebo)
STARTED   57   53 
COMPLETED   44   43 
NOT COMPLETED   13   10 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

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.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

immunoenzyme technique: Correlative studies

high performance liquid chromatography: Correlative studies

Total Total of all reporting groups

Baseline Measures
   Arm I (SAMe)   Arm II (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   53   110 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.5  (4.9)   57.2  (5.8)   57.88  (5.33) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  15.8%      6  11.3%      15  13.6% 
Male      48  84.2%      47  88.7%      95  86.4% 


  Outcome Measures

1.  Primary:   Change in Serum AFP Levels   [ Time Frame: Baseline to week 24 ]

2.  Secondary:   Treatment-related Changes in Serum DCP for Hepatocellular Carcinoma   [ Time Frame: Baseline to week 24 ]

3.  Secondary:   Treatment-related Changes in Serum AFP-L3 (Expressed as the Percentage of Total AFTP) for Hepatocellular Carcinoma   [ Time Frame: Baseline to week 24 ]

4.  Secondary:   SAMe   [ Time Frame: Baseline to week 24 ]

5.  Secondary:   Change in SAMe Metabolites - S-adenosylhomocysteine (SAH)   [ Time Frame: Baseline to week 24 ]

6.  Secondary:   Change in SAMe Metabolites - Methionine   [ Time Frame: Baseline to week 24 ]

7.  Secondary:   Change in SAMe Metabolites - Total Homocysteine (tHcy)   [ Time Frame: Baseline to week 24 ]

8.  Secondary:   Change in SAMe Metabolites - Plasma GSH   [ Time Frame: Baseline to week 24 ]

9.  Secondary:   Change in SAMe Metabolites - Malondialdehyde (MDA)   [ Time Frame: Baseline to week 24 ]

10.  Secondary:   Change in SAMe Metabolites - 4-hydroxynonenal (4-HNE)   [ Time Frame: Baseline to week 24 ]

11.  Secondary:   Change in Markers of Liver Disease - AST   [ Time Frame: Baseline to week 24 ]

12.  Secondary:   Change in Markers of Liver Disease - ALT   [ Time Frame: Baseline to week 24 ]

13.  Secondary:   HCV RNA   [ Time Frame: Baseline to week 24 ]

14.  Secondary:   Changes in Quality of Life - Physical Score   [ Time Frame: Baseline to week 24 ]

15.  Secondary:   Changes in Quality of Life - Mental Score   [ Time Frame: Baseline to week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Timothy R. Morgan
Organization: University of California, Irvine
phone: 562-826-5756
e-mail: timothy.morgan@va.gov


Publications of Results:

Responsible Party: Chao Family Comprehensive Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00513461     History of Changes
Other Study ID Numbers: UCI 06-07 / NCI-2009-00897
N01CN35160 ( U.S. NIH Grant/Contract )
CDR0000558657 ( Registry Identifier: PDQ (Physician Data Query) )
UCI04-3-01 ( Other Grant/Funding Number: NCI )
First Submitted: August 6, 2007
First Posted: August 8, 2007
Results First Submitted: August 24, 2017
Results First Posted: August 10, 2018
Last Update Posted: August 10, 2018