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| ID | Type | Description | Link |
|---|---|---|---|
| TMC435HPC3018 | Other Identifier | Janssen Infectious Diseases BVBA |
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The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or treatment-experienced.
This is a open-label (all people know the identity of the intervention), single arm, multicenter study. The study will consist of a screening phase up to 4 weeks, open-label treatment phase of 12 weeks, and post-treatment follow up phase up to 24 weeks after end of treatment. Approximately 100 participants will receive 150 mg simeprevir in combination with 400 mg sofosbuvir once dailyfor 12 weeks. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examination. The maximum study duration for each participant will be approximately 40 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Simeprevir/Sofosbuvir) | Experimental | 100 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simeprevir | Drug | 100 participants will receive 1 capsule of 150 mg orally once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT) | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the actual end of treatment. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT) | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the actual end of treatment. | Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Infectious Diseases BVBA Clinical Trial | Janssen Infectious Diseases BVBA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dothan | Alabama | United States | ||||
A total of 147 participants from the United States and Canada were Screened and 103 were enrolled into the study. All 103 participants who received at least 1 dose of study drug and so were included in intent to treat (ITT) population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sofosbuvir | Drug | 100 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks. |
|
| Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT) |
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 24 weeks after the actual end of treatment. |
| Week 36 |
| Percentage of Participants With On-treatment Virologic Response | On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. \ | Week 2, 4 and End of Treatment (Week 12) |
| Percentage of Participants With On-treatment Failure | On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment. | Week 12 |
| Percentage of Participants With Viral Breakthrough | Viral breakthrough was defined as confirmed greater than (>) 1 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA < LLOQ (25 IU/mL). | Up to End of Treatment (Week 12) |
| Percentage of Participants With Viral Relapse | Viral relapse was defined as participants who did not achieve SVR12 and had HCV RNA < LLOQ (25 IU/mL) undetectable at EOT and had HCV RNA >= LLOQ (25 IU/mL) during the follow-up period. | During the Follow-up (Week 24) |
| Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12 | The HCV-SIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively. | Baseline, Week 4, Week 12 and Follow-Up Week 12 |
| Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24 | The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7-point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue. | Baseline, Week 12, Follow-up Week 12 and 24 |
| Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D Scale assessed how often during the past week participants experienced 20 symptoms commonly associated with major depression. The CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5 to 7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores >=23 indicate probable major depressive illness. | Baseline, Week 12, Follow-up Week 12 and 24 |
| Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24 | The EQ-5D questionnaire was a brief, generic health-related quality of life (HRQOL) assessment that could also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assessed HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). | Baseline, Follow-up Week 12 and 24 |
| Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24 | Sequencing of the HCV nonstructural protein 3/4A (NS3/4A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. Sequencing data is available for 16 participants. | Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24 |
| Bakersfield |
| California |
| United States |
| Chula Vista | California | United States |
| Los Angeles | California | United States |
| San Diego | California | United States |
| Englewood | Colorado | United States |
| Bradenton | Florida | United States |
| Lauderdale Lakes | Florida | United States |
| Maitland | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Wellington | Florida | United States |
| Atlanta | Georgia | United States |
| Columbus | Georgia | United States |
| Marietta | Georgia | United States |
| Jackson | Mississippi | United States |
| Kansas City | Missouri | United States |
| Hillsborough | New Jersey | United States |
| Vineland | New Jersey | United States |
| New York | New York | United States |
| Asheville | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| East Greenwich | Rhode Island | United States |
| Providence | Rhode Island | United States |
| Greer | South Carolina | United States |
| Germantown | Tennessee | United States |
| Knoxville | Tennessee | United States |
| Nashville | Tennessee | United States |
| Arlington | Texas | United States |
| Austin | Texas | United States |
| San Antonio | Texas | United States |
| Norfolk | Virginia | United States |
| Vancouver | British Columbia | Canada |
| Montreal | Quebec | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT) | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the actual end of treatment. | Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 24 |
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| Secondary | Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT) | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the actual end of treatment. | Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 16 |
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| Secondary | Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT) | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 24 weeks after the actual end of treatment. | Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 36 |
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| Secondary | Percentage of Participants With On-treatment Virologic Response | On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. \ | Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point. | Posted | Number | Percentage of Participants | Week 2, 4 and End of Treatment (Week 12) |
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| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With On-treatment Failure | On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment. | Intent-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug. | Posted | Number | Percentage of Participants | Week 12 |
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| Secondary | Percentage of Participants With Viral Breakthrough | Viral breakthrough was defined as confirmed greater than (>) 1 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA < LLOQ (25 IU/mL). | Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. | Posted | Number | Percentage of Participants | Up to End of Treatment (Week 12) |
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| Secondary | Percentage of Participants With Viral Relapse | Viral relapse was defined as participants who did not achieve SVR12 and had HCV RNA < LLOQ (25 IU/mL) undetectable at EOT and had HCV RNA >= LLOQ (25 IU/mL) during the follow-up period. | Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | During the Follow-up (Week 24) |
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| Secondary | Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12 | The HCV-SIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively. | Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point. | Posted | Mean | Standard Error | Units on a Scale | Baseline, Week 4, Week 12 and Follow-Up Week 12 |
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| Secondary | Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24 | The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7-point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue. | Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point. | Posted | Mean | Standard Error | Units on a Scale | Baseline, Week 12, Follow-up Week 12 and 24 |
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| Secondary | Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D Scale assessed how often during the past week participants experienced 20 symptoms commonly associated with major depression. The CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5 to 7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores >=23 indicate probable major depressive illness. | Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point. | Posted | Number | Percentage of Participants | Baseline, Week 12, Follow-up Week 12 and 24 |
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| Secondary | Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24 | The EQ-5D questionnaire was a brief, generic health-related quality of life (HRQOL) assessment that could also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assessed HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). | Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point. | Posted | Mean | Standard Error | Units on a Scale | Baseline, Follow-up Week 12 and 24 |
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| Secondary | Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24 | Sequencing of the HCV nonstructural protein 3/4A (NS3/4A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. Sequencing data is available for 16 participants. | Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | Participants | Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24 |
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Baseline up to End of Treatment (Week 36)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. | 5 | 103 | 47 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Non-systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA Version 17.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA Version 17.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 17.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 17.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 17.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 17.1 | Non-systematic Assessment |
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A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director | Janssen Infectious Diseases - Diagnostics BVBA | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069616 | Simeprevir |
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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